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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: literature review
- Adequacy of study:
- other information
- Study period:
- 2013
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: literature review
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Principles of method if other than guideline:
- Literature review
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Results and discussion
Any other information on results incl. tables
See executive summary.
An inhalation acute toxicity test should not be required.
Applicant's summary and conclusion
- Executive summary:
CAE is defined as an UVCB substance (substance of unknown or variable composition). Its detailed chemical characterisation is presented in Table 1 (see PDF document attached).
The final complex is composed of glycerides (46.3%), free fatty acids and unsaponifiables such as alkyl furans, alkyl triols. More particularly alkyl furans are the result of chemical reaction during the heat treatment and are not found naturally in the fruit.
CAE was not experimentally tested for all requested toxicological end-points.
Glycerides and free fatty acids are very well-known substances which are not of toxicological concern. On the contrary, alkyl furans and alkyl triols, respectively named fraction H and fraction I, which are less well known, could raise questions about the toxicological profile of CAE.
In order to avoid unnecessary experimentation on animals, a literature review was performed for each component to determine their acute inhalation toxicity properties. The results are summarized in Table 2 (see PDF document attached).
According to available data, glycerides and free fatty acids have no inhalation acute toxicity. Other components are either of slight acute toxicity like alkyl furans with LC50expected between 1 and 4 mg/L/hr or of unknown toxicity like alkyl triols.
However all of these components have low vapour pressures (alkylfurans: 10-1-10-2 Pa), or extremely low vapour pressures (alkyl triols < 10-6 Pa).
Therefore, according to § 8.5.2. Column 2 in Annex VIII to Regulation (EC) No.1907/2006, testing by the inhalation route is not appropriate as exposure of humans via inhalation is unlikely, taking into account the low vapour pressure of the substance and the reduced possibility of exposure to aerosols, particles or droplets of an inhalable size (confinement during the manufacturing process).
An inhalation acute toxicity test should not be required.
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.