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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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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
Bioaccumulation: aquatic / sediment
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Administrative data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Executive summary:
The substance CAE (fats and glyceridic oils, avocado, unsaponifiable fraction, heat-treated, CAS No.1119235-20-9) is defined as an UVCB substance (substance of Unknown or Variable composition, Complex reaction products or Biological materials). It is composed of glycerides, free fatty acids and unsaponifiables. The detailed chemical characterisation of CAE is presented in section 1.2 of the IUCLID file.
The log Kow of CAE has not been determined experimentally. A literature review was performed for each component. The estimated log Kow values of all components of CAE range between 3.40 and 14.1. No experimental data is available for two alkyl triols; however, their content is very low (1.8% w/w total). Therefore, the log Kow value of CAE is expected to be > 3. Due to this high calculated octanol/water partition coefficient, CAE may have a tendency to bioaccumulate.
However, OECD 305 study is waived based on, technical, exposure and regulatory reasons:
Technical waiving: Before carrying out any of the bioaccumulation tests, the following information about the test substance should be known: - Sensitivity of the analytical technique for measuring tissue and water concentrations of both the test substance and possible metabolites;
- Solubility and stability in water;
- n-Octanol-water partition coefficient.
These pre-requisites are not fulfilled for CAE. Indeed, the solubility in water and the n-octanol-water partition coefficient were only estimated, but not quantified, for the main components of CAE.
Radiolabeling and Analytical Detection The use of radiolabeled CAE is not practical due to its UVCB nature: chemically modified natural substances. Without radiolabelling, the quantification of the parent "cold" ingredients in fish tissues and the identification of their metabolites would be impossible.
Exposure waiving: The readily biodegradability of CAE was assessed in 2 studies performed according to guidance OECD 301B. In the first study, the criterion for ready biodegradability was almost met with 56% and 57% biodegradation of CAE after 28 days. CAE can be considered as inherently biodegradable and therefore non persistent, according to this first study. This result was confirmed with the second study in which CAE was found to be readily biodegradable. The high level of biodegradation of CAE in these studies provides data which supports a non- exposure of aquatic organisms to CAE as there is no direct exposure of the environment to CAE and the indirect contamination is unlikely to pass through the sewage treatment plant into the surface water bodies.
Regulatory waiving Under Directive 86/609/EEC, it would be unjustifiable to use a vertebrate specie to define the bioaccumulation potential of CAE given the high probability that meaningful data would not be obtained given the complexities, technical difficulties and analytical restrictions discussed in this report.
Conclusion Therefore it appears that for technical and exposure reasons, a bioconcentration study according to OECD 305 is neither justified nor feasible for CAE which in any case is not a PBT substance, and should not be conducted according to Directive 86/609/EEC on the protection of vertebrates.
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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