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EC number: 200-467-2 | CAS number: 60-29-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline draft proposal for a new guideline, In Vitro Skin Irritation - reliability scoring based on 2009 guideline
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diethyl ether
- EC Number:
- 200-467-2
- EC Name:
- Diethyl ether
- Cas Number:
- 60-29-7
- Molecular formula:
- C4H10O
- IUPAC Name:
- diethyl ether
- Details on test material:
- - Name of test material (as cited in study report): Diethyl ether
- Physical state: Liquid (clear)
- Analytical purity: 99.93%
- Lot/batch No.: 09023198
- Expiration date of the lot/batch: 09/2010
- Stability under test conditions: Not reported
- Storage condition of test material: In a closed vessel at room temperature 20 ± 5 °C
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed epidermis model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- 30 µL
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- incubation for 42 hours and 47 minutes
- Number of replicates:
- 3
Test animals
- Species:
- other: Adult human-derived epidermal keratinocytes (Epi-200 tissues)
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Not applicable
ENVIRONMENTAL CONDITIONS
- Not applicable
Test system
- Type of coverage:
- other: None; test article was applied topically to tissues (in vitro), which were then covered with a nylon mesh to ensure sufficient contact
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: positive and negative control groups were provided
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL - Duration of treatment / exposure:
- Single exposure for 60 minutes (of which 35 minutes was at 37 °C)
- Observation period:
- Not applicable. See details under study design.
- Number of animals:
- Not applicable.
- Details on study design:
- This test consists of a topical exposure of a test article to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of 3-[4,5-dimethyl thiazole 2-yl]2,5-diphenyl-tetrazoliumbromide (MTT), present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential.
Pre-test:
The test article was tested for the ability of direct formazan reduction. The test article was added to MTT reagent and the mixture was incubated in the dark at room temperature for 60 minutes. Untreated MTT reagent was used as the control.
Main test:
The pre-incubated tissues were placed into wells containing assay medium. One plate (3 tissues) was used as the negative control and was treated with phosphate buffered saline. One plate was used as the positive control and was treated with sodium dodecylsulphate and another plate was used for treatment with the test article diethyl ether (a nylon mesh was added in order to ensure sufficient contact with the tissue surface). After an exposure period of 60 minutes (of which 35 minutes was at an incubation temperature of 37 °C), the tissues were rinsed and incubated with assay medium for 42 hours and 47 minutes. The tissues were then transferred into another 24-well plate and incubated with MTT reagent for approximately 3 hours. MTT reagent was then aspirated and replaced with phosphate buffered saline buffer and isopropanol was added. On the next day, formazan was extracted from the wells (2 replicates per well) and measured by determining the optical density at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three experiments
- Value:
- 112.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: values as percent absorbance; positive control was 10.6%
- Other effects / acceptance of results:
- Pre-test:
The MTT reagent didn’t change its color within 60 minutes, therefore, direct MTT reduction did not occur and no data correction was necessary.
Main test:
After the treatment, the relative absorbance values were increased to 112.4%. This value is well above the threshold for irritation (50%). Therefore, the test item is considered as not irritant.
Any other information on results incl. tables
As blank, the optical density of isopropanol was measured in 4 wells and the mean absorption value was determined as 0.43. From the measured absorptions for the negative control, positive control, and test article, the mean of each tissue was calculated, subtracting the mean absorption of isopropanol. The mean absorption values for the negative control, test article, and positive control were 2.005, 2.2253, and 0.213, respectively. For the test article and the positive control, the following percentage values for formazan production were calculated in comparison to the negative control, as shown in Table 2. The authors noted that the calculated value was more than 100% because the formazan production in the irritation test was higher than the negative control.
Table 2: % of Formazan Production |
||
Designation |
Diethyl Ether |
Positive Control |
% Formazan production (tissue 1) |
105.8 |
10.3 |
% Formazan production (tissue 2) |
113.5 |
11.1 |
% Formazan production (tissue 3) |
117.7 |
10.5 |
% Formazan production (mean) |
112.4 |
10.6 |
Validity of the results are shown in Table 3.
Table 3: Validity |
||
Criterion |
Demanded |
Found |
Optical density of negative control |
Between 1.0 and 2.5 |
2.005 |
% Formazan production of positive control |
≤ 20% of negative control |
10.6% |
Variation within replicates |
< 18% |
3.9% (negative control) 3.6% (positive control) 5.4% (test item) |
The values for the positive control were within the range of historical data of the test facility; however, the value for negative control was not within the range of historical data of the test facility. As the deviation was only 0.4% above the respective range of the historical data, the authors considered this result as uncritical. Variation of biological systems within this order of magnitude is not unusual and furthermore, different cell donors may have been used in the preparation of different batches of the cell cultures.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: other: CLP (EC 1272/2008)
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