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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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)
- 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 - 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 - 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)
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: respected breeders
- Age at study initiation:36 or 39 weeks
- Weight at study initiation:3.80 to 4.38 kg
- Housing: housed individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:21 or 22 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C):16 to 20°C
- Humidity (%):40 to 70%.
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12hrs/12hrs
IN-LIFE DATES: From: 26 October 2012 To: 15 November 2012 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- The eyelids were then gently held together for one second before releasing. The substance was not removed and the eyes were not washed.
- Observation period (in vivo):
- Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours and eight days after treatment
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: according to the system of Kay and Calandra (1962)
TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: Redness of conjunctiva - Mean score following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Redness of conjunctiva - mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Redness of conjunctiva - mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1, 24h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1, 24h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Injection of the conjunctival blood vessels and very slight or slight chemosis was evident in all animals during the first 24 hours following instillation; in two cases the conjunctival injection persisted throughout the first 72 hours after instillation. Slight or moderate discharge was apparent in all animals one hour after instillation. The treated eye of one animal was overtly normal by 48 hours after instillation and in the remaining two animals on Day 8. However, DEDG did not require labelling in accordance with European Commission regulation 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
Although an in vitro study, it was undertaken to GLP. Good reliable study (Klimish 2) performed with DEGMEE
Justification for selection of eye irritation endpoint:
Good reliable study (Klimish 1) undertaken to GLP and recognised international guideline and performed with the test substance.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The substance, DEGMEE, was found not to be corrosive but was found to be an irritant according to the RHE in vitro study and moderately irritating according to the rabbit in vivo report. This substance is used as read across for the classification of skin irritation of DEGDEE (see read across justification document). Therefore, taking the worst case scenario, DEGDEE is classified as an irritant. Under the DSD the classification will be Xi, R38 and under GHS/CLP, Skin irrit. 2, H315.
Instillation of DEGDEE into the eyes of three rabbits gave rise to some redness of the conjunctiva and chemosis. The highest total mean score was 8.0 occurring at the 1 hour observation; accordingly under the criteria Kay and Calandra (1962) DEGDEE was classified as “minimally irritating” to the eye. DEGDEE did not require labelling in accordance with European Commission regulation 1272/2008.
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