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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-01-17 to 2017-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 02 October 2012
- Deviations:
- no
- 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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: animal 1: approx. 44 weeks old; animal 2: approx. 41 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS-plastic or Noryl rabbit cages, floor 4200 cm², in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum - Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water (e.g. ad libitum): ad libitum - Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item was applied to the test site - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- The animals were observed for 72 hours after dosing. To determine the reversibility of the observed effects in animal no. 2, the observation period was extended up to 6 days after dosing.
- Number of animals or in vitro replicates:
- 2 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed after application.
SCORING SYSTEM: Grading system for ocular lesions according to OECD 405
TOOL USED TO ASSESS SCORE: At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution. The eyes were rinsed with physiological saline 0.9% NaCl after the examination.
TEST PROCEDURE:
Initial test: The in vivo test was performed initially using one animal.
Confirmatory test: The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response, one additional animal was treated in the same manner. According to OECD 405, section 23, treatment of a third animal was omitted as results from the second animal were sufficient to allow for hazard classification determination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- After the application into the eyes of two male NZW rabbits the test item produced slight irritant but not corrosive effects in both animals, which were fully reversible within 72 hours in animal no. 1 and within 6 days in animal no. 2. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal. Conjunctival redness, chemosis and hypersecretion were observed in both animals.
- Other effects:
- Neither mortality nor significant clinical signs of toxicity but local effects were observed. Moreover, the body weight development of all animals was within the expected range.
Any other information on results incl. tables
Table 1: Eye Irritation Scores - Animal No. 1 | ||||||||||
Observation | Animal No. 1, Eye Irritation Scores Post-Application After | Average Score (24, 48 and 72 hours) | ||||||||
1 hour | 24 hours | 48 hours | 72 hours | |||||||
Test item | Control | Test item | Control | Test item | Control | Test item | Control | |||
Redness | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0.67 | |
Chemosis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2: Eye Irritation Scores - Animal No. 2 | ||||||||||
Observation | Animal No. 2, Eye Irritation Scores Post-Application After | Average Score (24, 48 and 72 hours) | ||||||||
1 hour | 24 hours | 48 hours | 72 hours | |||||||
Test item | Control | Test item | Control | Test item | Control | Test item | Control | |||
Redness | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | |
Chemosis | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo acute eye irritation/corrosion study in rabbits, butyl ethyl ether was tested negative regarding irritation to the eye.
- Executive summary:
In a primary eye irritation study 0.1 mL of butyl ethyl ether (98.4 % purity) was applied into the conjunctival sac of one eye of two male New Zealand White Rabbits, Crl: KBL (NZW). The treated eye was not rinsed after the application. The untreated eye served as control. Control and treated animals were observed for a period of 72 hours.
Under the conditions of the present study, a single ocular application of the test item to rabbits at a dose of 0.1 mL produced slight irritant but not corrosive effects in both animals, which were fully reversible within 72 hours in animal no. 1 and within 6 days in animal no. 2. Neither mortalities nor significant clinical signs of toxicity were observed. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
On the basis of the test results and in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.
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