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EC number: 202-377-9 | CAS number: 94-96-2
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from published study in a peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology Update 2-Ethyl-1,3-hexanediol
- Author:
- Ballantyne B
- Year:
- 2 005
- Bibliographic source:
- J. Appl. Toxicol 25: 248-259
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize 1944 human patch testing
- Principles of method if other than guideline:
- Human volunteers received repeated applications of undiluted substance under occlusive patches for 3 weeks and dermal sensitisation (erythema and edema) was assessed.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-ethylhexane-1,3-diol
- EC Number:
- 202-377-9
- EC Name:
- 2-ethylhexane-1,3-diol
- Cas Number:
- 94-96-2
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2-ethylhexane-1,3-diol
- Test material form:
- liquid: viscous
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 203 male (n=31)and female (n=172) human volunteers
- Controls:
- Erythema and edema was compared with previous studies on the skin irritation potential of EHD.
- Route of administration:
- dermal
- Details on study design:
- During induction, single occlusive applications of 0.2 ml of EHD were made to the infrascapular skin three times a week for three consecutive weeks. Patches were left in contact for 24 h and then removed; the site was evaluated for local inflammatory reactions after a further 24 h. A rest period of 2 weeks followed the 3-week induction period. Then an occlusive challenge patch was applied for 24 h to an uncontaminated skin site. Challenge sites were evaluated 24 and 48 h after removal of the challenge patches.
Results and discussion
- Results of examinations:
- The incidence of marginal and definite erythematous responses was similar to that seen in previous skin irritation tests in human subjects (where mild skin irritation was observed). Twenty-one of 202 subjects showed a barely perceptible erythema and 2/202 subjects converted to a definite erythema during the induction phase. Two subjects showed a definite erythema 48 h after removal of the challenge patches. They were retested using occlusive and semi-occlusive patches applied to the skin of the flexor aspect of the arm. One subject demonstrated a definite erythema and edema under occlusive conditions, but the other subject showed only a questionable response. Thus there was clear evidence for a skin sensitizing response with only 1/203 subjects (0.5%), indicating that EHD is a weak skin sensitizer.
Any other information on results incl. tables
The skin reactions were compared to skin reactions in a 21-day cumulative occluded skin irritation test in humans.
Applicant's summary and conclusion
- Conclusions:
- 2-Ethylhexane-1,3-Diol is a weak human sensitiser, as one of 202 subjects who participated in a human Draize sensitization assay developed a definitive response. Mild dermal irritation was observed in two-four other participants.
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