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Tetrasodium [2-({4-fluoro-6-[(2-{[4-fluoro-6-({5-(hydroxykappaO)-6-[(2-{[2-(hydroxy-kappaO)-5-sulfophenyl] diazenyl-kappaN1}-4,5-dimethoxyphenyl) diazenyl-kappaN2]-7-sulfo-2-naphthyl} amino)-1,3,5-triazin-2-yl] amino} propyl) amino]-1,3,5-triazin-2-yl} amino) benzene-1,4- disulfonato(6-)] cuprate(4-)
EC number: 466-470-8 | CAS number: -
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Expert statement
- Adequacy of study:
- supporting study
- Study period:
- Study completion date - 16 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- other: Assessment of toxicokinetic behaviour
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment was performed based on available physico-chemical and toxicological data taking general principles of toxicokinetics into account.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Identity: FAT 40825/A
Batch number: CHU 297 / BOP 04/05
Purity: Organic part (Na-salt): approx. 83.7 %; All coloured components: approx. 80.54 %; Main component: approx. 59.1 %.
Appearance: Solid, black powder
Storage conditions: At room temperature at about 20 °C
Expiration date: December 31, 2010 - Details on absorption:
- The water solubility (341 g/l) and the partition coefficient (log Pow <-4.7) of Olive CHU 297 (FAT 40825/A) indicate a negligible potential for passive absorption by diffusion through cell membranes including dermal absorption, and a negligible bioaccumulation potential. The MMD was determined to be 4.6 μm, indicating that the substance has the potential to be inhaled.
- Details on distribution in tissues:
- The substance and its possible metabolites are anticipated to be distributed from the portal vein blood into the liver and into the kidneys where the soluble metabolites, including conjugated metabolites, are excreted via urine. Since the substance is hydrophilic, has a very low log Pow, and is ionisable, accumulation in fatty tissue is not expected.
- Metabolites identified:
- no
- Conclusions:
- FAT40825/A has a negligible potential for absorption by the dermal route and low resp. moderate potential for oral/inhalative absorption. Accumulation in tissue is not expected and thus a negligible bioaccumulation potential is expected.
- Executive summary:
The water solubility (341 g/l) and the partition coefficient (log Pow <-4.7) of Olive CHU 297 (FAT 40825/A) indicate a negligible potential for passive absorption by diffusion through cell membranes including dermal absorption, and a negligible bioaccumulation potential. The MMD was determined to be 4.6 μm, indicating that the substance has the potential to be inhaled.
The substance and its possible metabolites are anticipated to be distributed from the portal vein blood into the liver and into the kidneys where the soluble metabolites, including conjugated metabolites, are excreted via urine. Since the substance is hydrophilic, has a very low log Pow, and is ionisable, accumulation in fatty tissue is not expected.
Reference
Description of key information
FAT40825/A is expected to have a low bioaccumulation potential in the human body and also is poorly absorbed by oral and dermal route (10 % absorption expected conservatively). Due to its fine particle size the substance is capable of reaching the alveolar region in the lungs and thus inhalative absorption might be higher (80 % absorption rate proposed). However, it should be noted that FAT40825 is only placed onto the market in a dedusted form respectively in a granulated form and thus in practical handling and use inhalation of dust particles is technically minimized.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 80
Additional information
Due to the physico-chemical properties (i.e., high molecular weight, high water solubility, particle size is less than 10 µm, low LogPow) FAT40825/A is expected to be absorbed in human body via different routes - oral (assumed 10 %), dermal (assumed 10 %) and inhalation (assumed 80 %). Following absorption, FAT40825/A is anticipated to be distributed in blood, lung, liver and kidney. Excretion is expected via urine, bile or feces, and as a conclusion FAT 40825/A has a poor accumulation potential in the human body.
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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