Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- further information relevant for the PBT assessment is necessary
- Justification:
All studies referred to in this justification were performed in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. In addition, water solubility and Log Pow (by HPLC at pH ca. 6) were measured for FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of the studies conducted with FAT 41030 for read-across extrapolation to FAT 41045 is considered to be appropriate and the conclusions drawn regarding PBT and vPvB assessment are considered to be valid and identical for both substances.
Based on 0% degradation in two biodegradability studies with FAT 41030, the technical difficulties arising from low water solubility when testing FAT 41030 for abiotic degradability and the low water solubilty of FAT 41045, both FAT41030 and FAT 41045 are considered to be very persistent. From the high log Pow values (for FAT 41045 experimentally demonstrated to be > 6.2 at about pH 6) a bioaccumulation potential cannot be ruled out, but the very low water solubility of both substances (FAT 41030 < 2.7 µg/l in aquatic toxicity test medium) may limit their bioavailability to aquatic organisms thus hindering bioaccumulation. Therefore, the currently available data do not permit a final conclusion regarding the bioaccumulation potential of FAT 41030 or FAT 41045. PBT classification is inappropriate, because relevant toxicity was not evident in any of the available toxicology or ecotoxicology studies.
In conclusion, FAT 41030 and FAT 41045 are considered to be very persistent. A decision on bioaccumulation potential is currently not possible, although the log Pow > 6.2 for FAT 41045 indicates a potential for bioaccumulation. PBT classification is inappropriate, because relevant toxicity was not evident.
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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