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Diss Factsheets
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EC number: 304-059-6 | CAS number: 94233-27-9
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The target substance is hydrolytically unstable with hydrolysis half-life estimated to be less than 30 minutes, and with hydrolysis products being identified to be 2-ethylhexanol and acetylacetone. Because of the rapid hydrolysis, the influence of the target substance is related to its hydrolysis products.
2-ethylhexanol is the major hydrolysis product. It's toxicity property is used for read-across.
Data source
Reference
- Reference Type:
- publication
- Title:
- 2-Ethylhexanol
- Author:
- BG-Chemie
- Year:
- 1 995
- Bibliographic source:
- Toxikologische Bewertungen, Programm zur Verhütung von Gesundheitsschädigungen durch Arbeitsstoffe
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Assessment of human data. Review of patch test data on humans following exposure of 2-ethylhexanol
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Existing study conducted on human and adopted by peer-revieed journal.
Test material
- Reference substance name:
- 2-ethylhexan-1-ol
- EC Number:
- 203-234-3
- EC Name:
- 2-ethylhexan-1-ol
- Cas Number:
- 104-76-7
- Molecular formula:
- C8H18O
- IUPAC Name:
- 2-ethylhexan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 4%, 1mL
- Day(s)/duration:
- 28 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 4%, 0.4ml
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 29
- Details on study design:
- Skin areas were pretreated with 5% sodium lauryl sulphate for 24 h. The induction was then performed four times for 28 h each with a cotton cloth soaked in a 4% solution of EH in paraffin oil. The challenge was performed with 4% EH for 48 h.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not specified.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin sensitisation was not observed in a study on 29 volunteers using patch test method. 2-ethylhexanol was concluded non-sensitsing.
- Executive summary:
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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