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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 performed according to OECD guideline 439 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- 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]
- Reference substance name:
- Polyesterol 90212
- IUPAC Name:
- Polyesterol 90212
- 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
Constituent 2
Test animals
- Species:
- other: 3D human epidermis model
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 30 ul of undiluted test substance.
- Duration of treatment / exposure:
- 25 minutes under the laminar flow hood at room temperature and for 35 minutes in the incubator at 37 °C.
- Details on study design:
- PRETEST
A pretet to assess the ability of the test substance to directly reduce MTT was performed. The test substance was added to 0.9 ml of MTT solution. The mixture was incubated in the dark at 37 °C for 55-65 minutes. A negative control with dioinized water was tested concurrently.
SKIN IRRITATION TEST
The EpiDerm test was conducted with the Epi-200 tissue model (MatTek Corporation, Ashland MA, USA). The tissues were preconditioned in 6-well-plates containing 0.9 ml assay medium in the incubator at 37 °C for 1 hour. After that, the medium was replaced with fresh medium and the tissues were preconditioned for another 18+/-3 hours. The tissues were then treated with the test substance and positive (5% SDS) and negative (PBS) controls, respectively (3 tissues per group). A nylon mesh was placed on the control tissues as spreading support. The tissues were incubated at room temperature for 25 minutes and in the incubator for 35 minutes. 1 hour after application, the tissues were washed with PBS, dried, transferred into new 6-well-plates containing fresh medium and incubated at 37 °C for 24+/-2 hours. Subsequently, the tissues were again transferred into new 6-well-plates containing fresh medium and incubated for additional 18+/-2 hours of post-incubation. The medium was then replaced with MTT solution. After 3 hours of incubation, the tissues were washed and incubated with isopropanol to extract the metabolically formed formazan. The optical density at 570 nm was determined spectrophotometrically.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: tissue viability, presented as the quotient of the mean OD570 divided by the respective OD570 NC value in %.
- Value:
- > 50 - <= 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Max. score: 100.0. Reversibility: no data. Remarks: A chemical is considered as irritant if the mean relative tissue viability is <=50%.. (migrated information)
Any other information on results incl. tables
ACCEPTANCE CRITERIA
Negative control:
Tissue viability is acceptable if the mean OD570 of the negative control is >=1.0 (should not exceed 2.5).
Positive control:
5% SDS is used as positive control and reflects the sensitivity of the tissues used. A viability of <=20% is acceptable.
Inter-tissue variability between two identically treated tissues is considered to be acceptable if the standard deviation is <=20%.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Irritant potential is predicted from the mean relative tissue viabilities compared to the negative control. A chemical is considered as "irritant", if the mean relative tissue viability is <=50%.
- Conclusions:
- Under the test conditions chosen, Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] does not show a skin irritation potential in the EpiDerm skin irritation test.
- Executive summary:
The test substance Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] was tested for skin irritation in the EpiDermTM test following OECD guideline 439 with the Epi-200 tissue model (MatTek Corporation, Ashland MA, USA). The tissues were preconditioned first for 1 hour and after a medium change for another 18+/-3 hours. Subsequently, the test substance and positive (5% SDS) and negative (PBS) controls, respectively, were applied (3 tissues per group). The tissues were incubated at room temperature for 25 minutes and in the incubator for 35 minutes. 1 hour after application, the tissues were washed, dried, and incubated at 37 °C for 24+/-2 hours, followed by a 18+/-2 hours post-incubation period. The medium was then replaced with MTT solution. After 3 hours of incubation, the tissues were washed and incubated with isopropanol to extract the metabolically formed formazan. The optical density at 570 nm was determined spectrophotometrically. Irritant potential was predicted from the mean relative tissue viabilities compared to the negative control. A chemical is considered as "irritant", if the mean relative tissue viability is <=50%. The tissues treated with the test substance showed a mean relative viability of 99%. Based on these results, it can be concluded that under the test conditions chosen, Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] is not irritating in the EpiDerm skin irritation test.
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