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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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)
Description of key information
A paper-based toxicokinetic assessment has been conducted for this substance (see IUCLID section 13 as attachment). Available studies were reviewed by a qualified toxicologist. The assessment of the likely toxicokinetic behaviour of the test item was provided to the extent that can be derived from the relevant available information at the time of the assessment. The available information suggests that the test item is not readily bioavailable via the oral, dermal or inhalation routes. This is supported by the physico-chemical and toxicological properties of the test item. If any absorption occurs, the test item would most likely be distributed systemically in the serum. Urinary excretion is considered to be the significant route for the test item.
The absorption, distribution, metabolism and excretion of FAT 40868/A TE has been predicted based on the following information:
FAT 40868/A TE being highly water soluble 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.
The available evidence including single and 90 Day Repeated Oral (Gavage) Toxicity Studies together with a repeated dose reproductive screening oral gavage study indicated the test item and/or its predicted metabolites to have only low toxic potential when absorbed or distributed through the gastro-intestinal tract and serum.
Excretion of FAT 40868/A TE and any of its predicted metabolites is expected to be from urine and faeces with the latter likely to be a result of unabsorbed material.
The studies conducted for FAT 40868/A TE provided evidence to indicate absorption will primarily take place in the gastrointestinal tract following oral ingestion with some absorption potentially also taking place via the skin; once absorbed, the test substance would primarily be distributed in the serum. There was no evidence to indicate test item or metabolite influenced hepatic metabolism. Excretion of the test substance and/or its metabolites would be predominantly via the urine and faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
The available information suggests that absorption of the test item through the skin, gastro-intestinal tract or via inhalation is unlikely or very limited (a worst case of 10% for all routes is assumed). If absorbed, the test item may be distributed in the serum. Elimination in urine may be the significant route of excretion for any material that is absorbed and accumulation in tissue is not expected due to the negative logPow and the high water solubility.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.