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EC number: 614-587-1 | CAS number: 68551-92-8
- 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
Endpoint summary
Administrative data
Description of key information
Skin:
- Skin irritation, EpiDerm™ skin irritation test, OECD 439: viability 89-114%, non-irritant (BASFSE, 2012, 61V0072/12A112)
Eye:
- Eye irritation, EpiOcularTM Eye Irritation Test, according to MatTek 2010/ Harbell J.W. et al. (2009): viability 98.7-104.6%, non-irritant (BASFSE, 2012, 62V0072/12A113)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are valid in vitro study data available assessing the irritating potential of Fatty acids, C18-unsatd., dimers, ethoxylated to skin and eye. There are not in vivo studies available or proposed due to Annex XI, Section 1.4 (see waiver statement)
Skin:
OECD guideline conform studies:
The potential of the test substance to cause dermal irritation was assessed by a single topical application of 30μL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™)(BASFSE, 2012, 61V0072/12A112). Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The EpiDerm skin irritation test showed the following results: The test substance is able to reduce MTT directly. The mean viability of the test substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 114%. As visible residues of the test substance were observed on the tissues after washing an influence of the test substance due to direct MTT reduction had to be excluded. Therefore a second test run was performed with an additional MTT reduction control. The mean viability of the test substance treated tissues for the 2nd test run was 89%. The ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing used during the 2nd test run. Based on the observed results and applying the evaluation criteria cited in chapter 3.8 it was concluded, that Fatty acids, C18-unsatd., dimers, ethoxylated does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.
Key study assignment skin irritation:
As there is only one relevant and reliable study available assessing the skin irritation of Fatty acids, C18-unsatd., dimers, ethoxylated and no further results are available, this study is therefore included as key study.
Assessment skin irritation:
All available information is taken into account to assess the skin irritating potential of Fatty acids, C18-unsatd., dimers, ethoxylated. The results are derived from a scientific valid in vitro method show a cell viability of 89-114%, hence the substance is considered as non-irritant.
Eye irritation:
other guideline conform studies:
The potential of Fatty acids, C18-unsatd., dimers, ethoxylated to cause ocular irritation was assessed by a single topical application of 50μL of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™) according toMatTek 2010/Harbell J.W. et al. (2009) (BASFSE, 2012, 62V0072/12A113). Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results: The test substance is able to reduce MTT directly. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing. The mean viability of the test-substance treated tissues was 102%. Based on the observed results and applying the evaluation criteria it was concluded, that Fatty acids, C18-unsatd., dimers, ethoxylated does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
Key study assignment skin irritation:
As there is only one relevant and reliable study available assessing the eye irritation of Fatty acids, C18-unsatd., dimers, ethoxylated and no further results are available, this study is therefore included as key study.
Assessment eye irritation:
All available information is taken into account to assess the eye irritating potential of Fatty acids, C18-unsatd., dimers, ethoxylated. The results are derived from well-known highly reliable in vitro eye irritation test (EpiOcularTM Eye Irritation Test) show a cell viability of 98.7-104.6%, hence the substance is considered as non-irritant.
Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study.
Justification for selection of eye irritation endpoint:
GLP compliant and current methods followed study.
Justification for classification or non-classification
Skin:
Based on the available information from skin irritation study were no hints for irritation were observed, the substance has not be classified according to EU, UN-GHS (EC 1272/2008 ) or DSD (67/548/EEC).
Labelling for skin irritation:
GHS: no classification
DSD: no classification
Eye:
Based on result of the eye irritation study to the test substance, classification and labelling is not warranted according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
Labelling for eye irritation:
GHS: no classification
DSD: no classification
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