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EC number: 211-112-6 | CAS number: 629-82-3
- 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:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.39
- Max. score:
- 1.39
- Reversibility:
- fully reversible
- 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%.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): di-n-octylether
- Physical state: colorless liquid
- Purity: >99.9%
- Stability: stable at temperatures up to 40°C - Species:
- rabbit
- Strain:
- other: Kleinrussen Chbb:HM
- Details on test animals or tissues and environmental conditions:
- according to guideline
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- application volume: 0.1 mL undiluted
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- according to guideline
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - < 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 1.5
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2.5
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- edema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 2
- Reversibility:
- fully reversible within: 72 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Only mild effects were observed that were fully reversible within 3 days. Therefore, the substance is considered to be slightly irritating.
- Executive summary:
An aliquot of 0.1 ml aqueous solution of the test article 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. GHS criteria for classification and labelling are not fulfilled.
Reference
Table 1: Evaluation of the eye reactions
Animal No. |
Hours after application |
|||||||||||||||||||
1 |
24 |
48 |
72 |
|||||||||||||||||
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
A |
B |
C |
D |
L |
|
1270 1272 1273 |
0 0 0 |
0 0 0 |
1 2 1 |
1 1 0 |
1 1 0 |
0 0 0 |
0 0 0 |
1 1 0 |
0 1 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
A effects on cornea (turbidity degree)
B effects on iris (intensity)
C erythema (conjunctival reaction)
D edema (conjunctival reaction)
L lacrimation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute skin irritation:
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.
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%. 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 the test article 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.
Based on the reliability and relevance, this study has been used as key study.
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
Based on results of the key studies for skin irritation and for eye irritation, the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008).
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