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Diss Factsheets
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EC number: 278-031-6 | CAS number: 74931-55-8
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Study period:
- May 25, 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment was performed for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) based on experimental data identified for its parent acid and amine components.
Data source
Reference
- Reference Type:
- other: Expert assessment
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment was undertaken to determine the capacity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) to induce chromosome aberration in mammalian cells by review of reliable experimental data identified in the literature for the parent acid and amine components; 2-ethylhexanoic acid and 2-aminoethanol.
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
- EC Number:
- 278-031-6
- EC Name:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
- Cas Number:
- 74931-55-8
- Molecular formula:
- C10H23NO3
- IUPAC Name:
- 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)
- Test material form:
- liquid
- Details on test material:
- - Density: 0.999 g/cm3
Constituent 1
Results and discussion
Test results
- Key result
- Species / strain:
- other: Rat lymphocyte cells; rat hepatocytes (RL4)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: 2-Ethylhexanoic acid and 2-aminoethanol did not induce gene mutation in bacteria with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- An assessment was undertaken based on experimental data identified for the parent acid and amine components; 2-ethylhexanoic acid and 2-aminoethanol, of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1). The registered substance is not expected to induce structural chromosomal aberration in mammalian cells and an experimental study is not required.
- Executive summary:
To fulfil Annex VIII of REACH Regulation (EC) No. 1907/2007, the capacity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) to induce structural chromosomal aberration in mammalian cells was evaluated. No experimental data was identified for 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) for structural chromosomal aberration in mammalian cells following an extensive review. Therefore, experimental data identified for the parent acid and amine components; 2-ethylhexanoic acid and 2-aminoethanol, relating to in vitro structural chromosomal aberration in mammalian cells was reviewed for the purpose of the endpoint assessment. Given that the registered substance will dissociate in the event of exposure and its acid and amine components will behave independently in water, the mutagenicity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) is anticipated to be driven by 2-ethylhexanoic acid and 2-aminoethanol. The study results indicated that the components were negative for structural chromosomal aberration in mammalian cells with and without metabolic activation and were regarded as reliable without restriction (Klimisch score = 1) or reliable with restrictions (Klimisch score = 2). According to the activity of the two components, 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) is not expected to induce structural chromosomal aberration in mammalian cells. An experimental study is not 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.
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