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EC number: 618-460-1 | CAS number: 9010-89-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to scientifically valid methods and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Assessment of ocular irritation by a single topical application of the test substance to a reconstructed 3D human cornea model (EpiOcularTm eye irritation test).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol]
- EC Number:
- 618-460-1
- Cas Number:
- 9010-89-3
- Molecular formula:
- (C6 H10 O4 . C4 H10 O3)x
- IUPAC Name:
- Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol]
- Test material form:
- other: liquid
- Details on test material:
- ca. 99% (w/w) Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] / Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] / 9010-89-3
IMPURITIES
ca. 2% (w/w) 2,3,7,8-tetrahydro-2,5,8-benzotrioxacycloundecine-1,9-dione / 1,4,7-Trioxacyclotridecane-8,13-dione / 1,4,7-Trioxacyclotridecane-8,13-dione / 6607-34-7
ca. 10 ppm tin bis(2-ethylhexanoate) / Bis(2-ethylhexanoyloxy)tin / Hexanoic acid, 2-ethyl, tin(2+) salt (2:1) / 301-10-0
ca. 10 ppm titanium tetrabutanolate / titanium tetrabutanolate / tetrabutyl titanate / 5593-70-4
Constituent 1
Test animals / tissue source
- Species:
- other: 3D human cornea model
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 50 ul of undiluted test substance
- Duration of treatment / exposure:
- 30 minutes
- Observation period (in vivo):
- 2 hours post-incubation
- Details on study design:
- The EpiOcularTM assay is designed to predict an eye irritation potential of a chemical based on the observation that irritant chemicals produce cytotoxicity in human reconstructed cornea after a short-term topical exposure. Cytotoxicity is expressed as a reductionof the activity of mitochondrial dehydrogenase, which reduces the yellow water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolim bromide (MTT) to the insoluble blue formazan in the test medium. Thus,the loss of viability of the tissues is measured by a colorimetric assay after administration of the substance.
For the EpiOcularTM assay, the OCL-200 model supplied by MatTEK Corp. (Ashland MA, USA) was used. Methyl acetate was used as a positive control.
Two tissues were treated with the test compound, the positive control and negative control, respecitvely. Tissues were incubated in sterile 6-well plates with 1 ml assay medium at standard culture conditions for 16-24 hours. After that, tissues were treated with 20 ul of PBS at standard culture conditions for 30 minutes to wet the tissue surface. 50 ul of the undiluted test substance were then applied covering the whole tissue surface, . Control tissues were concurrently treated with 50 ul of de-ionized water (negative control) or methyl acetate (positive control). After that, the tissues were incubated until the total exposure time of 30 minutes was completed. To remove the test substance, the tissues were washed with PBS and transferred to pre-warmed medium for 12 minutes to remove residual test substance. The tissues were then dried, transferred to 6-well-plates filled with pre-warmed medium and incubated at standard culture conditions for 2 hours of postincubation. After that, the assay medium was replaced by 0.3 ml MTT solution (1 mg/ml in assay medium) and the tissues were placed in the incubator for 3 hours. After incubation, tissues were washed with PBS and subsequently incubated in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker to extract the metabolically produced formazan. The OD570 of the extracts was then determined spectrophotometrically.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: tissue viability, presented as the quotient of the mean OD570 divided by the respective OD570 NC value in %.
- Score:
- > 60
- Reversibility:
- not specified
- Remarks on result:
- other: A substance is considered to be non-irritant in the EpiOcular test if the mean tissue viability is >60% of the negative control.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: The irritation potential is predicted from the mean relative tissue viabilities as compared to the negative control tissues according to the following criteria: <=50% --> irritant; >50 <=60% --> no prediction; >60% --> non-irritant.
- Conclusions:
- Under the test conditions chosen, Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] does not show an eye irritation potential in the EpiOcular eye irritation test.
- Executive summary:
Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] was tested for eye irritation potential in the EpiOcularTM assay. 50 ul of the undiluted test substance were applied to a reconstructed 3D human cornea model (two tissue samples per treatment group). Negative (de-ionized water) and positive controls (methyl acetate) were run concurrently. The tissues were incubated with the test or control substances for 30 minutes, followed by a 2 hour post-incubation period. Formazan production after incubation with MTT was measured as indicator for cytotoxicity. The ratio of formazan production in the test substance-treated tissues and that in the negative control tissues indicates relative tissue viability. The test substance was not able to reduce MTT, and the mean viability of the test substance-treated tissues was 102%. Based on these results, it was concluded that the test substance does not show an eye irritation potential in the EpiOcularTM test under the test conditions chosen.
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