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Diss Factsheets
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EC number: 271-351-7 | CAS number: 68541-71-9
- 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 in vivo
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Expert assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of toxicokinetic behaviour based on physicochemical properties and toxicology data
- GLP compliance:
- no
- Specific details on test material used for the study:
- Substance name: FAT 20011/E TE
Batch/Lot number: 1309023 (China)
Appearance: Dark blue solid
Purity: 61.2%
pH: 7.9 [Conc. (% w/w): 1%]
Molecular weight†: 791.55 g/mol - Conclusions:
- The available information suggests that absorption of FAT 20011/E TE will primarily take place in the gastrointestinal tract following oral ingestion. Some absorption may also take place via damaged skin. Once absorbed, the substance would primarily be distributed in the serum with excretion via the urine and faeces.
- Executive summary:
The absorption, distribution, metabolism and excretion of FAT 20011/E TE has been predicted based on the following information:
FAT 20011/E TE; the available information indicates absorption in all probability would be via the gastrointestinal tract subsequently entering the circulatory system in the blood. This assertion was supported by results from a repeated dose reproductive screening study performed for FAT 20011/E TE.
Supplementary information indicated FAT 20011/E TE to be potentially slightly irritant to the skin and eyes and to be a skin sensitizer. However, the evidence from the single dose oral toxicity and repeated oral dose reproductive screening studies performed for FAT 20011/E TE confirmed the test item has minimal toxic potential.
FAT 20011/E TE on the basis of supporting information is considered not to present a risk of uptake via the inhalation route.
FAT 20011/E TE the evidence from the repeated dose reproductive screening study showed that FAT 20011/E TE and/or its predicted metabolites have the potential for systemic distribution throughout the body although the repeated dose study indicated little evidence of systemic toxicity.
The studies conducted for FAT 20011/E 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 predominantly be via the urine and faeces.
Reference
The substance composed is a dark blue solid with a molecular weight of 791.55 g/mol. The predicted self-ignition temperature (low volatility), melting point and particle size indicate the substance is unlikely to present a significant hazard via the inhalation route which is further supported by the fact that the test product is intended for industrial and professional use only in the form of dedusted granules or liquid formulations.
The substance has a low log octanol/water partition coefficient value (Log Pow 0.291) and high water solubility (200 g/L).
The available repeated dose reproductive screening study showed evidence of absorption, distribution metabolism and probable routes of excretion. Read across data from a closely related test item indicated FAT 20011/E TE to be potentially irritant to the skin and eyes, to be a skin sensitizer and potentially mutagenic (in bacteria). The acute oral toxicity results for FAT 20011/E TE indicated the LD50 to be >3000 mg/kg body weight and an oral gavage combined toxicity reproductive and developmental toxicity study with FAT 20011/E TE showed no convincing evidence of systemic toxicity nor any adverse effects on maternal or developmental toxicity up to a dose level of 1000 mg/kg/day.
Description of key information
The absorption, distribution, metabolism and excretion of FAT 20011/E TE has been predicted based on the following information:
FAT 20011/E TE; the available information indicates absorption in all probability would be via the gastrointestinal tract subsequently entering the circulatory system in the blood. This assertion was supported by results from a repeated dose reproductive screening study performed for FAT 20011/E TE. Supplementary information indicated FAT 20011/E TE to be potentially slightly irritant to the skin and eyes and to be a skin sensitizer. However, the evidence from the single dose oral toxicity and repeated oral dose reproductive screening studies performed for FAT 20011/E TE confirmed the test item has minimal toxic potential. FAT 20011/E TE on the basis of supporting information is considered not to present a risk of uptake via the inhalation route. FAT 20011/E TE the evidence from the repeated dose reproductive screening study showed that FAT 20011/E TE and/or its predicted metabolites have the potential for systemic distribution throughout the body although the repeated dose study indicated little evidence of systemic toxicity. The studies conducted for FAT 20011/E 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 predominantly be via the urine and faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no 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.
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