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Diss Factsheets
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EC number: 279-365-5 | CAS number: 80010-51-1
- 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: Evaluation based on physicochemical and in vivo data
- Adequacy of study:
- key study
- Study period:
- 21 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Objective of study:
- toxicokinetics
- Qualifier:
- according to guideline
- Guideline:
- other: Expert Statement
- Principles of method if other than guideline:
- Toxicokinetic behaviour was evaluated based on physicochemical and in vivo data.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Substance name: FAT 21036/G TE
Batch/Lot number: AT-0033945200
Appearance: Blue solid
Purity: 64.5 %
Molecular weight: 669.52 g/mol
Specific gravity: 1.6400 mg/mL - Preliminary studies:
- From the information provided it has been concluded that the absorption of FAT 21036/G would primarily take place in the gastrointestinal tract following oral ingestion with some absorption potentially also capable of taking place via damaged skin albeit uptake via intact skin is considered unlikely to occur. FAT 21036/G once absorbed would in all probability be distributed in serum with excretion via the urine and faeces.
- Metabolites identified:
- not measured
- Conclusions:
- From the information provided it has been concluded that the absorption of FAT 21036/G would primarily take place in the gastrointestinal tract following oral ingestion with some absorption potentially also capable of taking place via damaged skin albeit uptake via intact skin is considered unlikely to occur. FAT 21036/G once absorbed would in all probability be distributed in serum with excretion via the urine and faeces.
- Executive summary:
The absorption, distribution, metabolism and excretion of FAT 21036/G has been predicted based on the physico-chemical properties and supporting toxicological information provided for FAT 21036/G.
FAT 21036/G is indicated to be highly water soluble and would most likely following oral administration be absorbed in the gastro-intestinal tract with subsequent systemic distribution taking place via the serum.
The physico-chemical properties indicate the risk of inhalation to be minimal and in the event any did take place the available supporting toxicological information indicates no elevated toxicity would be anticipated. There was no confirmatory evidence to indicate how FAT 21036/G or any of its intermediate products are metabolised however the hydrophilic nature of FAT 21036/G would suggest passage across biological membranes would be limited.
Furthermore, the histopathological evidence derived from a repeated dose toxicity study with an analogue of FAT 21036/G provided no conclusive evidence of test item or metabolite influenced hepatic metabolism. Neither was there evidence to confirm the route of excretion; nevertheless, it is reasonable to assume that due to FAT 21036/G being highly water soluble clearance would likely be via the urine with any remaining test item not absorbed being excreted in the faeces. Based on review of the available information it has therefore been concluded the risk of systemic toxicity from FAT 21036/G would be minimal.
Reference
Description of key information
The absorption, distribution, metabolism and excretion of FAT 21036/G has been predicted based on the physico-chemical properties and supporting toxicological information provided for FAT 21036/G. FAT 21036/G is indicated to be highly water soluble and would most likely following oral administration be absorbed in the gastro-intestinal tract with subsequent systemic distribution taking place via the serum. The physico-chemical properties indicate the risk of inhalation to be minimal and in the event any did take place the available supporting toxicological information indicates no elevated toxicity would be anticipated. There was no confirmatory evidence to indicate how FAT 21036/G or any of its intermediate products are metabolised however the hydrophilic nature of FAT 21036/G would suggest passage across biological membranes would be limited. Furthermore, the histopathological evidence derived from a repeated dose toxicity study with an analogue of FAT 21036/G provided no conclusive evidence of test item or metabolite influenced hepatic metabolism. Neither was there evidence to confirm the route of excretion; nevertheless, it is reasonable to assume that due to FAT 21036/G being highly water soluble clearance would likely be via the urine with any remaining test item not absorbed being excreted in the faeces. Based on review of the available information it has therefore been concluded the risk of systemic toxicity from FAT 21036/G would be minimal.
Key value for chemical safety assessment
Additional information
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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