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Diss Factsheets
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EC number: 955-212-4 | 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
Endpoint summary
Administrative data
Description of key information
Additional information
The registration of the test material employs a combined approach for addressing the required endpoints. When data are not available, data from the read across substances are used to address the required endpoints.
The read across substances are structurally similar to registered substance. The substance and the proposed structural analogues are predominantly C32 – C36 alkyl fatty amides. These substances are expected to be metabolised by fatty acid amide hydrolase and esterases. Any differences among the substance structures are not expected to result in any significant differences in the toxicological effects or degradation products.
The following endpoints include supporting studies to provide evidence of read across suitability:
• Water solubility
• Partition Coefficient
Physical state
The test material is a tan colour solid block at room temperature.
Melting / freezing point
In an OECD 102 study, conducted according to GLP, the melting point of the test material is 85.1°C.
Boiling point
In an OECD 103 study, conducted according to GLP, the boiling point of the test material is greater than 400°C.
Relative density
In an OECD 109 study, conducted according to GLP, the relative density of the test material is 0.915 at 20°C.
Granulometry
According to 7.14 Column 2 Annex VII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the granulometry (particle size) of a substance does not need to be conducted if the substance is marketed, or used, in the EU in a non-solid or granular form. Although the test material is a solid at room temperature due to the physical nature of the test material (a waxy solid block), the particle size distribution could not be determined according to European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances (2002); therefore, this endpoint is waived.
Vapour pressure
In an OECD 104 study, conducted according to GLP, the vapour pressure of the test material is less than 0.0042 Pa at 25¿.
Partition coefficient n-octanol/water
Key Study:
In an OECD 117 study conducted according to GLP, the Partition Coefficient of the test material is log Pow greater than 6.5 at 20°C.
Supporting Studies:
In an EU Method A8 study, not conducted according to GLP, the Partition Coefficient of the structurally similar read across substance is greater than 5.7 at 23°C.
In an EU Method A8, not conducted according to GLP, the Partition Coefficient of the structurally similar read across substance is log Pow greater than 5.7 at 23°C.
Water solubility
Key Study:
In an OECD 105 study, conducted according to GLP, the water solubility of the test material is less than 0.0506 mg/L, and is therefore considered insoluble in water.
Supporting Studies:
In an EU Method A.6 study, not conducted according to GLP, the water solubility of the structurally similar read across substance is less than 0.01 mg/L.
In an EU Method A.6 study, not conducted according to GLP, the water solubility of the structurally similar read across substance is less than 0.05 mg/L.
Surface tension
The study does not need to be conducted because water solubility is below 1mg/L at 20°C. This study is waived.
Flash point
The study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids. The study is waived.
Autoflammability / self-ignition temperature
In an EU Method A15 study, conducted according to GLP, the auto-ignition temperature of the test material is 384±5¿.
Flammability
In an EU Method A10 study, conducted according to GLP, the test material is not flammable as it failed to ignite in the preliminary screening test. The result of the preliminary screening test obviated the need to perform the main test.
Explosive properties
In an EU Method A.14 study, conducted according to GLP, the structures of the test material was assessed for chemical groups that imply explosive properties. There are no structural alerts within the chemical structure of the test material. Based on the chemical structures of the test material the result for the explosive properties is predicted negative.
Oxidising properties
In an EU Method A.21 study, conducted according to GLP, the structures of the test material is assessed for chemical groups that imply oxidising properties. There are no structural alerts within the chemical structure. Based on the chemical structures of the test material the result for the oxidising properties is predicted negative.
Stability in organic solvents and identity of relevant degradation products
The study does not need to be conducted because the stability of the substance is not considered to be critical. This endpoint has been waived.
Dissociation constant
Due to the very low water solubility of the test material (less than 0.0506 mg/L), a physical study could not be completed, therefore an OECD Guideline 112 was not carried out. Computer estimation, conducted within a laboratory, under GLP conditions, gave pKas for the amide nitrogen at 16.4 and -0.48.
Viscosity
The study does not need to be conducted because the substance is a solid. This endpoint has been waived.
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.