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EC number: 203-987-8 | CAS number: 112-58-3
- 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
skin irritation (human): slightly irritating
eye irritating (rabbit): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Human Patch Test, GCP compliant
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Cetiol OE
- Lot/batch No.: 1029/8
- Physical state: Colorless liquid
- Purity: 99.9% - Species:
- human
- Strain:
- other: caucasian
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 70 µL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 19 volunteers
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.39
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substances was rated as beeing non-irritant to humans.
- Executive summary:
Dioctylether was tested in an occlusive 4-hr patch test. 19 volunteers were treated with the undiluted test substance and with a 50% concentration of dioctylether in 2-hexyl decanol. As a positive standard 2% Sodium Dodecyl Sulfate (SDS) was used which is classified as an irritant substance at a concentration of 2 %. The positive standard SDS 2% caused slight, moderate, strong and very strong reactions in 16 out of 19 volunteers, while the undiluted dioctylether caused slight and single moderate erythema in 8 out of 19 volunteers. The 50% concentration of dioctylether caused single slight erythema in 2 out of 19 volunteers. Thus, the reactions caused by dioctylether were significantly lower than the reactions caused by SDS 2%.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Klimisch criteria
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen Chbb:HM
- Details on test animals or test system and environmental conditions:
- according to guideline
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days after patch removal
- Number of animals:
- 3
- Details on study design:
- according to guideline
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible
- Remarks:
- within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible
- Remarks:
- within 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Other effects:
- none
- Interpretation of results:
- moderately irritating
- Conclusions:
- Based on the results of this study, the substance is considered to be moderately irritating.
- Executive summary:
The acute dermal irritation of the test substance was tested undiluted (100% active matter) in 3 albino rabbits, strain New Zealand White. The contact time under semi-occlusive conditions was four hours. The 24/48/72 hours scores were 2.7 for the erythema and 2.3 for the oedema. The reactions disappeared totally within 21 days.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Dioctyl ether is a structural closely-reated dialkyl ether with only slightly longer C-chains. The toxicological profile of the read-across substance show a high similarity to dihexyl ether.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.39
- Reversibility:
- fully reversible
- Remarks on result:
- other: test in human
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.39
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: test in human
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: test in human
- Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test substance was tested in an occlusive 4-hr human patch test. 19 volunteers were treated with the undiluted test substance and with a 50% concentration of dioctylether in 2-hexyl decanol. As a positive standard 2% Sodium Dodecyl Sulfate (SDS) was used which is classified as an irritant substance at a concentration of 2 %. The positive standard SDS 2% caused slight, moderate, strong and very strong reactions in 16 out of 19 volunteers, while the undiluted dioctylether caused only slight and single moderate erythema in 8 out of 19 volunteers. The 50% concentration of dioctylether caused single slight erythema in 2 out of 19 volunteers. Thus, the reactions caused by dioctylether were significantly lower than the reactions caused by SDS 2%.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 26 to Sugust 31, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted for the notification in China where authorities do not accept non-animal nor read-across data for the endpoint eye irritation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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: 46 weeks (animal 1) and 54 weeks (animal 2)
- Weight at study initiation: 3.7 kg (animal 1) and 3.8 kg (animal 2)
- Housing: ABS-plastic or Noryl rabbit cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10x/h
- Photoperiod (hrs dark / hrs light): 12 dark/ 12 h light)
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 0.9 % NaCl
- Time after start of exposure: after 24 h - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- - Lesions and clinical observations: none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, the substance dihexyl ether is not irritating to the eyes.
- Executive summary:
An acute eye irritation study was performed according to OECD Test Guideline 405.
After the application into the eyes of two male NZW rabbits the test item produced slightly irritant but not corrosive effects in two animals.
Animal no. 1 showed conjunctival redness score 1 from 1 hour to 24 hours after application. Chemosis score 1 was observed in this animal 1 hour after application.
Application of the test item in the eye of animal no. 2 led to conjunctival redness score 2 after 1 hour and decreased to score 1 24 hours post-application. Chemosis score 1 was recorded 1 hour after application. In both animals the effects were reversible within up to 48 hours post-application.
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Neither mortalities nor significant clinical signs of toxicity or local effects were observed. However, animal no. 1 reacted very sensitive 1 hour after application, when touching the treated eye.
Based on the result of this study, the substance dihexyl ether is not irritating to the eyes.
Reference
Animal no. 1 showed conjunctival redness score 1 from 1 hour to 24 hours after application. Chemosis score 1 was observed in this animal 1 hour after application.
Application of the test item in the eye of animal no. 2 led to conjunctival redness score 2 after 1 hour and decreased to score 1 24 hours post-application. Chemosis score 1 was recorded 1 hour after application. In both animals the effects were reversible within up to 48 hours post-application.
Neither mortalities nor significant clinical signs of toxicity or local effects were observed. However, animal no. 1 reacted very sensitive 1 hour after application, when touching the treated eye.
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute skin irritation:
No skin irritation study is available for the substance dihexyl ether. In an acute dermal toxicity study in rats no local effects were observed at the application area after the exposure time of 24 hours.
In addition the data of the structurally related substance dioctyl ether (see below) can be used for read-across to assess the skin irritant properties of dihexyl ether. The dialkylether dioctyl ether shows a comparable toxicological profile as dihexyl ether. The data on eye irritation show the same low potential for eye irritation in rabbits as dihexyl ether. Dihexyl ether shows even less effects in the rabbit eye than the read-across substance dioctyl ether.
There are two studies with the read-across substance dioctyl ether.
In the first study the acute dermal irritation of dioctyl ether was tested undiluted (100% active matter) in 3 albino rabbits, strain New Zealand White. The contact time under semi-occlusive conditions was four hours. The 24/48/72 hours scores were 2.7 for the erythema and 2.3 for the oedema. The reactions disappeared totally within 21 days.
Dioctylether was also tested in an occlusive 4-hr patch test in humans. 19 volunteers were treated with the dioctyl ether and with a 50% dilution of dioctylether in 2-hexyl decanol. As a positive standard 2% Sodium Dodecyl Sulfate (SDS) was used which is classified as an irritant substance at this concentration. The positive standard SDS 2% caused slight, moderate, strong and very strong reactions in 16 out of 19 volunteers, while the undiluted dioctylether caused slight and single moderate erythema in 8 out of 19 volunteers. The 50% concentration of dioctylether caused single slight erythema in 2 out of 19 volunteers. Thus, the reactions caused by dioctylether were significantly lower than the reactions caused by SDS 2%. Therefore, dioctylether was rated to be slightly irritating. A classification is not justified.
Based on the higher relevance of the test result obtained in the human study compared to the animal test, the human patch test has been used as key study.
Acute eye irritation:
An aliquot of 0.1 ml aqueous solution of
dihexyl ether was instilled by a single application for a 24h contact
into the eyes of 3 rabbits. The eyes were scored 24, 48 and 72 hours
after application. The 24/48/72 hours mean scores were 0 for the cornea,
0 for the iris, 0.33 for the conjunctival erythema and 0.11 for the
conjunctival oedema. The conjunctiva reactions abated completely within
72 hours. In summary, only mild effects were observed that were fully
reversible. Therefore, the substance is considered to be slightly
irritating.
Justification for classification or non-classification
Based on data on the structurally-related substance dioctyl ether for skin irritation and a study on eye irritation, the substance dihexyl ether does not need to be classified according to GHS (Regulation (EU) 1272/2008).
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