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Diss Factsheets
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EC number: 944-699-9 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Expert assessment
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- An expert assessment was performed by a qualified toxicologist.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,5-diaminobromo-4,8-dihydroxyanthraquinone
- EC Number:
- 250-817-3
- EC Name:
- 1,5-diaminobromo-4,8-dihydroxyanthraquinone
- Cas Number:
- 31810-89-6
- Molecular formula:
- C14H9BrN2O4
- IUPAC Name:
- 1,5-diamino-2-bromo-4,8-dihydroxy-9,10-anthraquinone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: FAT 36002/G TE
Lot: DX201409-01
Appearance: Dark blue powder
Constituent 1
- Specific details on test material used for the study:
- None
Results and discussion
Any other information on results incl. tables
TOXICOKINETIC BEHAVIOUR
The substance composed, as listed in Section 3 is a blue solid with a molecular weight of ~362 g/mol and
to have low water solubility and high melting and auto-ignition points. The supporting physicochemical
properties together with the inhalable particle size fraction of ~2% at <100 μm indicate low
volatility which together with supporting toxicological results indicate the risk of particle inhalation to be
minimal. Genotoxicity assays all proved negative (non-mutagenic) and a single dose toxicity study
established the oral LD50 to be >1000 mg/kg body weight. Derivatives of FAT 36002/G TE were shown
to be mildly irritative to the skin and eyes and in all likelihood to cause skin sensitization. A rodent
repeated dose oral (gavage) combined toxicity and reproduction/developmental toxicity screening
(OECD 422) study conducted on a closely related chemical provided evidence of absorption,
distribution, metabolism and excretion.
Absorption
The low water solubility and high octanol/water partition coefficient would inhibit passage across
biological membranes. However, generalized blue staining of both external and internally body surfaces
and organs together with evidence of staining in the faeces and bedding that were identified in the OECD
422 study would indicate some passive absorption would occur through the gastro-intestinal tract
following oral ingestion before entering the circulatory system via the blood. Further information
indicated the test material may be a skin sensitizer implying injury to the skin barrier could increase the
chances of test item penetration with subsequent binding to carrier proteins in the circulatory system.
Distribution
The physico-chemical properties suggest the possibility that some accumulation in adipose tissue could
occur. However, the results from the OECD 422 study provided sufficient evidence to establish the most
probable route of absorption and systemic distribution to take place along the gastrointestinal tract and
serum.
Metabolism
The results of the repeated dose oral (gavage) combined toxicity and reproduction/developmental toxicity
screening (OECD 422) study did not show any evidence of test material influenced hepatic metabolism.
The results of the genotoxicity assays also proved negative. Furthermore, while the physico-chemical
properties might suggest the test material to be lipophilic the supporting evidence strongly suggest that
metabolism to a more hydrophilic product to actuate excretion would take place.
Excretion
The most plausible route of clearance for low water soluble materials such as FAT 36002/G TE would be
by transfer of test material and/or metabolites from the plasma to the bile through the hepatocytes and
then by way of a process known as enterohepatic cycling the final clearance of any metabolic breakdown
products would primarily be via the faeces. To further support this viewpoint, dark blue stained faeces
were identified from animals of all test groups in the OECD 422 study.
CONCLUSION
The available information suggests that absorption of FAT 36002/G TE will primarily take place in the
gastrointestinal tract following oral ingestion. Some absorption may also take place via the skin. Once
absorbed, the substance would primarily be distributed in the serum with excretion primarily being via
the faeces.
Applicant's summary and conclusion
- Conclusions:
- The available information suggests that absorption of FAT 36002/G TE will primarily take place in the
gastrointestinal tract following oral ingestion. Some absorption may also take place via the skin. Once
absorbed, the substance would primarily be distributed in the serum with excretion primarily being via
the faeces. - Executive summary:
The absorption, distribution, metabolism and excretion of FAT 36002/G TE has been predicted based on
the physico-chemical properties and supporting toxicological information provided for FAT 36002/G TE.
FAT 36002/G TE would in all probability be absorbed via the gastrointestinal tract subsequently entering
the circulatory system in the blood. It is also possible some absorption could take place through the skin.
However, the risk of uptake via the inhalation route was considered to be low as the test material was not
volatile and the available supporting toxicological information would suggest no elevation in systemic
toxicity would be expected.
The available evidence including single dose and repeated dose oral (gavage) combined toxicity study
with reproduction /developmental toxicity screening test in the rat indicated the test item and/or its
predicted metabolites to have only low toxic potential when absorbed or distributed through the gastrointestinal
tract and serum.
Excretion of FAT 36002/G TE and any of its predicted metabolites is expected to be primarily from the
faeces.
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