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EC number: 211-055-7 | CAS number: 628-81-9
- 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:
- 2016-11-10 to 2016-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Butyl ethyl ether
- EC Number:
- 211-055-7
- EC Name:
- Butyl ethyl ether
- Cas Number:
- 628-81-9
- Molecular formula:
- C6H14O
- IUPAC Name:
- 1-ethoxybutane
- Test material form:
- liquid
- Details on test material:
- - Source and batch No.of test material: 60930023
- Expiration date of the batch: 09/2021
- Purity: 98.4%
- Physical State: liquid
- Density: 0.75 g/cm³
- Colour: colourless
- Storage condition of test material: Keep container tightly closed. Store in a dry and cool area
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Justification for test system used:
- This test uses the EPISKIN-SM™ reconstructed human epidermis model (SkinEthic) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. This test method is able to detect chemicals that cause skin irritation, i.e. produce reversible damage to the skin and allows for hazard identification in accordance with UN GHS "Category 2". Depending on the regulatory framework it can also be used to identify non-classified chemicals.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:
The test was carried out with the reconstituted three-dimensional human skin model EPISKIN-SM™ (SkinEthic). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts. A highly differentiated and stratified epidermis model is obtained after 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
- Tissue batch number(s): 16-EKIN-046
- Expiration date: November 21, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation (if applicable):
a) 37 ± 1 °C (5.0% CO2 for 42 ± 1 h) in 2 mL pre-warmed fresh maintenance medium
b) 37 ± 1 °C (5.0% CO2 for 3 h ± 5 min) in 2 mL pre-warmed MTT medium
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps:
* washed with DPBS; excess DPBS was removed by blotting bottom with blotting paper;
* after post-incubation: excess medium was removed by blotting bottom on absorbent paper
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h ± 5 min at 37 ± 1 °C, 5.0% CO2.
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
- Filter bandwidth: ± 30 nm
NUMBER OF REPLICATE TISSUES: 3 tissues per dose group
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered irritant to the skin if the viability after 15 minutes exposure and 42 h of post-incubation is less or equal to 50%. Further testing is required to resolve between UN GHS categories 1 and 2 and decide on the final classification of the test substance
- The test substance is considered to be non-corrosive to skin if the viability after 15 minutes exposure and 42 h is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL (26.3 µL/cm²) of the test item was dispensed directly atop the EPISKIN-SM tissue using a positive displacement pipette. The test item was spread to match size of the tissue.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL DPBS (Gibco, Cat. No. 14040-091, Lot No.: 1737107)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL 5% sodium dodecyl sulfate (SDS; AppliChem, Art.-No. A1112,0500, CAS No.: 151-21-3, Lot No.: 40015277) in aqua dest. - Duration of treatment / exposure:
- 15 ± 0.5 min
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three tissues
- Value:
- 73.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- For detailed results see box "Any other information on results".
Any other information on results incl. tables
Results of the Pre-Experiments
The mixture of 10 µL test item per 2 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixtures of 10 µL of the test item per 90 µL aqua dest. and per 90 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSCliving equalled 0%.
Table 1: Results of the test item butyl ethyl ether
Name | Negative Control | Positive Control | Test Item | ||||||
Tissue | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Absolute OD570 | 0.760 0.824 |
0.715 0.735 |
0.741 0.795 |
0.235 0.182 |
0.176 0.180 |
0.185 0.153 |
0.573 0.573 |
0.532 0.523 |
0.607 0.618 |
OD570 (Blank corrected | 0.717 0.781 |
0.672 0.693 |
0.698 0.752 |
0.192 0.139 |
0.133 0.137 |
0.142 0.110 |
0.531 0.530 |
0.489 0.480 |
0.565 0.575 |
Mean OD570 of the Duplicates (Blank corrected) | 0.749 | 0.683 | 0.725 | 0.166 | 0.135 | 0.126 | 0.530 | 0.485 | 0.570 |
Total Mean OD570 of 3 Replicate Tissues (Blank corrected) | 0.719* | 0.142 | 0.528 | ||||||
SD OD570 | 0.034 | 0.021 | 0.043 | ||||||
Relative Tissue Viabilities [%] | 104.2 | 94.9 | 100.9 | 23.0 | 18.8 | 17.6 | 73.7 | 67.4 | 79.3 |
Mean Relative Tissue Viabilities [%] | 100.0 | 19.8** | 73.5 | ||||||
SD Tissue Viabilities [%]*** | 4.7 | 2.9 | 5.9 | ||||||
CV [% Viability] | 4.7 | 14.5 | 8.1 |
* Corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is ≤ 40%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%.
Table 2: Test Acceptance Criteria
|
Value |
Cut off |
pass/fail |
Mean OD570Blank |
0.043 |
< 0.1 |
pass |
Mean Absolute OD570NK |
0.762 |
0.6 ≤ NK ≤ 1.5 |
pass |
Mean Relative Viability PC [%] |
19.8 |
≤ 40% |
pass |
Max. SD of % Viability |
5.9 |
≤ 18% |
pass |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no irritant effects in an in vitro skin irritation study conducted according to OECD 439.
- Executive summary:
In an in vitro skin irritation study according to OECD Guideline 439 (Reconstructed Human Epidermis Test), the potential of buthl ethyl ether (98.4% purity) to induce skin irritation was analysed by using the three-dimensional human skin model EPISKIN-SM™ (SkinEthic) comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EPISKIN-SM™ tissue for 15 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The test item showed no irritant effects and is therefore considered to be non-irritating to the skin.
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