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Diss Factsheets
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EC number: 276-602-4 | CAS number: 72363-26-9
- 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 assessment
- Adequacy of study:
- supporting study
- 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
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- An expert assessment was performed by a qualified toxicologist using physical-chemical properties and available toxicological data.
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Conclusions:
- The available information suggests that any absorption of FAT 40444/B will primarily take place in the gastrointestinal tract following oral ingestion. Once absorbed, the substance most likely would be distributed in the serum with excretion primarily being via the faeces.
- Executive summary:
No absorption, distribution, metabolism and excretion studies are available for FAT 40444/B. Therefore, the toxicokinetic assessment of this test item has been predicted based on its physico-chemical properties and on the available toxicological study data that has been provided. The information available indicates absorption of the test substance following oral administration would take place via the gastrointestinal tract and once absorbed, the substance may be distributed in the serum. Supporting information would suggest the risk of systemic toxicity from oral, skin and eye contact or from particle inhalation to be minimal. There is no evidence suggesting how the test substance may be metabolised nor studies performed to identify metabolites. However, the results of the genotoxicity assays all proved negative. Excretion of FAT 40444/B and any of its predicted metabolites is expected to be primarily from the faeces.
Reference
Absorption
The vapour pressure value is very low and the molecular weight relatively high exposure making the risk of inhalation exposure unlikely. A single oral dose toxicity study provided no evidence of systemic toxicity. Furthermore, the relatively high octanol-water partition coefficient would mean there would be limited passage of FAT 40444/B across biological membranes.
Distribution
There is minimal information available relating to the distribution of FAT 40444/B. However, the low water-solubility and general physico-chemical characteristics would imply the most probable route of absorption would take place along the gastrointestinal tract with potential systemic distribution via serum. The lack of evidence to suggest the test item is a skin sensitizer suggests that it would not bind to carrier proteins in the circulatory system. Furthermore while there is also a potential for accumulation in adipose tissue to occur the studies conducted showed no evidence of this and that where it to occur the risk of systemic toxicity would be minimal.
Metabolism
There are no repeated dose studies available to indicate if the test item is subjected to hepatic metabolism. However, the results of the genotoxicity assays have shown that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising system.
Excretion
The most plausible route of clearance for low water soluble materials such as FAT 40444/B would be by transfer of test material and/or metabolites from the plasma to the bile through the hepatocytes leading to clearance of any metabolic breakdown products primarily via the faeces.
Description of key information
No absorption, distribution, metabolism and excretion studies are available for FAT 40444/B. Therefore, the toxicokinetic assessment of this test item has been predicted based on its physico-chemical properties and on the available toxicological study data that has been provided. The information available indicates absorption of the test substance following oral administration would take place via the gastrointestinal tract and once absorbed, the substance may be distributed in the serum. Supporting information would suggest the risk of systemic toxicity from oral, skin and eye contact or from particle inhalation to be minimal. There is no evidence suggesting how the test substance may be metabolised nor studies performed to identify metabolites. However, the results of the genotoxicity assays all proved negative. Excretion of FAT 40444/B and any of its predicted metabolites is expected to be primarily from the faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
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.
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.