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Diss Factsheets
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EC number: 203-963-7 | CAS number: 112-36-7
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 13 to 15 January 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study undertaken at GLP accredited laboratory to internationally accepted guidelines but performed with DEGDME a substance used for read across. DEGDME is like DEGDEE part of the diethylene glycol monoalkyl and dialkyl ethers category. These substances have been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile (see Category Approach-Read across Diethylene Glycol Diethyl Ether, 2013). Therefore, a read-across from DEGDEE to data obtained with DEGDME is scientifically justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline In Vitro Skin Irritation: Human Reconstructed Epidermis (RhE) Test Method, Version 4, 11 December 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-ethoxy-2-(2-methoxyethoxy)ethane
- EC Number:
- 213-690-5
- EC Name:
- 1-ethoxy-2-(2-methoxyethoxy)ethane
- Cas Number:
- 1002-67-1
- Molecular formula:
- C7H16O3
- IUPAC Name:
- 1-ethoxy-2-(2-methoxyethoxy)ethane
- Reference substance name:
- Diethylene glycol methyl ethyl ether
- IUPAC Name:
- Diethylene glycol methyl ethyl ether
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Diethylene glycol methyl ethyl ether
- Physical state: Colourless liquid
- Analytical purity: > 99.8% (w/w)
- Impurities (identity and concentrations):
- Purity test date: 12 November 2009
- Lot/batch No.: DEG4055316
- Expiration date of the lot/batch: 02 December 2010
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Human Epidermis
- Source: SkinEthic, 45 rue Saint Philippe-Le Palmeira, 06000 Nizza, France
- Age at study initiation: Foreskin Age 4 years
Test system
- Type of coverage:
- open
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 20 µl - Duration of treatment / exposure:
- Quality control; 4h (±15min)
Positive control; 42 min (± 1 min)
Negative control; 42 min (± 1 min)
Test substance; 42 min (± 1 min) - Details on study design:
- Supplier: SkinEthic, 45 rue Saint Philippe-Le Palmeira, 06000 Nizza, France
Lot No.: 09 022A 1211
Origin: Foreskin Age 4 years
Expiration date: 2010-01·18: day 24 of airlifted culture
Supplier's quality controls: Cell viability at day 17 (MTT test, n=2):
Specification: OD > 0.7 Result: OD = 1.287 ± 0.164
Validity references: Statement on the scientific validity of in-vitro tests for skin irritation testing. Endorsement from the Commission members of the ECVAM Scientific Advisory Committee (ESAC). 29th meeting; 4-5th November, 2008 at the European Commission in Brussels
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Optical density
- Value:
- 1.966
- Remarks on result:
- other:
- Remarks:
- Basis: mean (Negative control). Time point: 42h. Remarks: Viability (mean) 100%. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density
- Value:
- 0.029
- Remarks on result:
- other:
- Remarks:
- Basis: mean (postive control). Time point: 42h. Remarks: Viability (mean) 1.5%. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density
- Value:
- 0.373
- Remarks on result:
- other:
- Remarks:
- Basis: mean (Diethyleneglycol EM). Time point: 42h. Remarks: Viability (mean) 19.0%. (migrated information)
Any other information on results incl. tables
After topical application of the test substance Diethylenglycol EM had an unpredictable macroscopic interactions of the test substance diethylenglycol ethyl methyl ether with the inner surface of the cell culture insert. To our present knowledge it remains unclear, if the observed interactions may also have affected the test performance and the corresponding test result.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this in vitro skin irritation study, Diethylenglycol methyl ethyl ether is predicted as a category 2 skin irritant.
- Executive summary:
DEGDEE and DEGMEE, which is in the above study tested for its skin irritation, are both part of the diethylene glycol monoalkyl and dialkyl ethers category described and evaluated in the document titled "Category Approach-Read across Bis(2 -ethoxyethyl)ether" (2013).
These substances have been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile . Therefore, a read-across from DEGDEE to data obtained with DEGMEE is scientifically justified.
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