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EC number: 205-575-3 | CAS number: 142-96-1
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dibutyl ether
- EC Number:
- 205-575-3
- EC Name:
- Dibutyl ether
- Cas Number:
- 142-96-1
- Molecular formula:
- C8H18O
- IUPAC Name:
- 1-butoxybutane
- Details on test material:
- - Name of test material (as cited in study report): n-dibutylether
- Physical state: colourless liquid
- Analytical purity: > 99.3%
- Purity test date:
- Lot/batch No.: 0000093881
- Expiration date of the lot/batch: December 19, 2004
- Stability under test conditions:
- Storage condition of test material: in tightly closed container, in a cool, well ventilated place, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT laboratory of Pharmacology and Toxicology KG, branch Lohndorf, D-24601 Lohndorf/Post Wankendorf
- Age at study initiation: young adults - approximately 4 months
- Housing: during the exposure period, kept singly in restrainers, durimg the acclimatisation and after the 4-hour exposure period, the animals were housed singly in cages with dimensions (425 x 600 x 380 mm)
- Diet (e.g. ad libitum): ad libitumbefore and after the exposure period
- Water (e.g. ad libitum): ad libitumbefore and after the exposure period.
- Acclimation period: at least 20 adpatation days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Concentration: 0.5 ml undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- After the 4-hour exposure period, the patch was removed and the resulting reactions were examined. Scores were noted at 60 minutes, 24, 48, 72 hours and 4 days after patch removal
- Number of animals:
- 3
- Details on study design:
- The test was performed on three male rabbits (strain Himalayan, initial body weight 2.2 to 2.3 kg, age approx. 4 months at start of the adaptation period of at least 20 days). Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Only animals with healthy intact skin were used. A dose of 0.5 ml was applied to the test site (area: approx. 6 cm³) and then covered with a gauze patch. The patch was held in contact with skin by means of a semi-occlusive dressing (non-irritating tape) for 4 hours. The surrounding untreated skin served as control. After the 4-hour exposure period the patch was removed and the resulting reactions were examined. Scores were taken 60 minutes, 24, 48, 72 hours and 4 days after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no edema observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no edema observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no edema observed
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A very slight erythema (barley perceptible, grade 1) was observed in all animals 60 minutes and 24 hours after patch removal. In two animals the very slight (barley perceptible) erythema persisted until 72 hours after patch removal. A very slight oedema (barley perceptible, grade 1) was observed in two animals 60 minutes after patch removal. All effects were reversible within 4 days after patch removal. The mean scores of the 24, 48, and 72 hour readings for erythema were 1.0, 1.0, and 0.3 for the three test-animals, respectively, and for oedema 0.0 for all three test-animals. The mean scores of the 24, 48 and 72 hour readings do not exceed the limit values according to directive 93/21 EEC in any case.
- Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data in this irritation study it can be stated that dibutyl ether showed very slight irritant but no corrosive effects. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) dibutyl ether does not have to be classified and has no obligatory labelling requirements for skin irritation in reference to this test result. Classification: not irritating
- Executive summary:
The study was conducted according to OECD TG 404, EC Method B.4 and in accordance with the Principles of Good Laboratory Practice (GLP). The test was performed on three male rabbits (strain Himalayan, initial body weight 2.2 to 2.3 kg, age approx. 4 months at start of the adaptation period of at least 20 days). Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Only animals with healthy intact skin were used. A dose of 0.5 ml was applied to the test site (area: approx. 6 cm³) and then covered with a gauze patch. The patch was held in contact with skin by means of a semi-occlusive dressing (non-irritating tape) for 4 hours. The surrounding untreated skin served as control. After the 4-hour exposure period the patch was removed and the resulting reactions were examined. Scores were taken 60 minutes, 24, 48, 72 hours and 4 days after patch removal. A very slight erythema (barley perceptible, grade 1) was observed in all animals 60 minutes and 24 hours after patch removal. In two animals the very slight (barley perceptible) erythema persisted until 72 hours after patch removal. A very slight oedema (barley perceptible, grade 1) was observed in two animals 60 minutes after patch removal. All effects were reversible within 4 days after patch removal. The mean scores of the 24, 48, and 72 hour readings for erythema were 1.0, 1.0, and 0.3 for the three test-animals, respectively, and for oedema 0.0 for all three test-animals. There were no systemic intolerance reactions noted. Based on the results noted, n-dibutylether will not be classified as a skin irritant.
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