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EC number: 210-734-5 | CAS number: 622-40-2
- 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: Modern guideline study conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- There are no official national or international guidelines for the EpiOcularTM test yet; however, the study was performed according to the methods described in the following publications:
MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1a of February 10, 2010.
Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing In Vitro Eye Irritation Assays for Entry into Formal Validation: Technology
Transfer and Intra/Inter Laboratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, Society of Toxicology, March 2009.
In addition the study follows the testing strategy for determination of eye irritation/corrosion as given in the following OECD guideline:
OECD Guideline for Testing of Chemicals No. 405, April 24, 2002 (“Acute Eye Irritation/Corrosion”) - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-morpholinoethanol
- EC Number:
- 210-734-5
- EC Name:
- 2-morpholinoethanol
- Cas Number:
- 622-40-2
- Molecular formula:
- C6H13NO2
- IUPAC Name:
- 2-(morpholin-4-yl)ethan-1-ol
- Test material form:
- other: liquid
- Details on test material:
- Name of test substance:
2-Morpholinoethanol
Test-substance No.:
11/0386-1
Batch identification:
B 1262 vom 21.09.2011
CAS No.:
622-40-2
Purity:
99.7 area-% (for details see report No.: 11L00465)
Homogeneity:
The test substance was homogeneous by visual inspection.
Storage stability:
The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Constituent 1
Test animals / tissue source
- Species:
- other: non-keratinized tissue construct composed of normal human derived epidermal keratinozytes
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative and positive control
- Duration of treatment / exposure:
- undiluted liquid test substance was applied covering the whole tissue surface
- Observation period (in vivo):
- after application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: optical density [wavelength 570 nm]
- Basis:
- mean
- Time point:
- other: after 30 minutes exposure
- Score:
- 0.326
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: optical density [wavelength 570 nm]
- Basis:
- mean
- Time point:
- other: after 30 minutes exposure
- Score:
- 0.534
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: optical density [wavelength 570 nm]
- Basis:
- mean
- Time point:
- other: after 30 minutes exposure
- Score:
- 1.856
- Remarks on result:
- other: negative control
- Irritation parameter:
- other: tissue viability [% of negative control]
- Basis:
- mean
- Time point:
- other: after 30 minutes exposure
- Score:
- 18
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: tissue viability [% of negative control]
- Time point:
- other: after 30 minutes exposure
- Score:
- 29
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: tissue viability [% of negative control]
- Time point:
- other: after 30 minutes exposure
- Score:
- 100
- Remarks on result:
- other: negative control
Applicant's summary and conclusion
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that 2-Morpholinoethanol shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
- Executive summary:
The potential of 2-Morpholinoethanol to cause ocular irritation was assessed by a single topical application of 50 µL of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™). 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. Therefore an additional MTT reduction control was introduced. 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 18 %. Based on the observed results it was concluded, that 2-Morpholinoethanol shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen. The test method does not yet allow for the evaluation of serious eye damage. The result does not exclude a serious eye irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed (see 63V0386/11A583).
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