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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data published in a peer reviewed journal.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- publication
- Title:
- Toxicology Update 2-Ethyl-1,3-hexanediol
- Author:
- Ballantyne
- Year:
- 2 005
- Bibliographic source:
- J. Appl. Toxicol 25: 248-259
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Six rabbits had 0.1 ml of undiluted EHD instilled into the inferior conjunctival sac, and further groups of six rabbits had 0.01 or 0.005 ml of EHD applied directly to the cornea
- 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
- Details on test material:
- - Name of test material (as cited in study report):2-EthylHexan-1,3-Diol
- Substance type: Aliphatic Alcohol
- Physical state: Liquid; slightly viscous
- Analytical purity: 98.5
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Body weights: 2.0 to 3.0 kg.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Six rabbits had 0.1 ml of undiluted EHD applied to the conjunctival sac.
Six rabbits had 0.01 or 0.005 ml of EHD applied directly to the cornea of the eye. - Duration of treatment / exposure:
- 14 days
- Observation period (in vivo):
- Eyes were inspected periodically: 1 and 24 h, and 2, 3 and 7 to 14 days after dosing, for signs of ocular and periocular inflammation and injury up to 14 days post-dosing.
- Number of animals or in vitro replicates:
- 12 Animals. 6 had EHD instilled into the inferior conjunctival sac and six rabbits had EHD applied directly to the cornea
- Details on study design:
- The Draize scale was used for evaluation (Draize J.H., Woodard G., Calvery H.O. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. And Exp. Therapeutics 82: 377–390.)
Results and discussion
In vivo
Results
- Irritation parameter:
- other:
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- >= 80
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Following 0.1 ml of EHD there was a rapid development of mild to severe conjunctivitis (moderate to marked injection, mild to severe chemosis, mild to marked discharge), which took up to 7 days to resolve. A moderate iritis was seen that persisted for 24–48 h. A just detectable to moderate corneal injury was seen in five out of six rabbits, which persisted for 3–7 days. With the smaller volume of EHD applied to the cornea there was a moderate to severe conjunctivitis for 24 h post-instillation but the effects required 2–7 days to resolve. Scores for irritation were not provided. These were estimated based on the conclusions of the study.
- Other effects:
- In one animal the conjuntivitis resolved rapidly, and the eye appeared normal by 24 hr post instillation. However,
in the remaining 5 animals the conjunctival infection persisted from 3-7 days.
Any other information on results incl. tables
Summary of Scores for Eye Lesion Observed After the Instillation of Various Volumes of EHD into the Eyes of Rabbits
Effect as Average (and range) | |||||||
Volume | Observation | Cornea | Iris | Conjunctivae | |||
(ml) | Opacity | Area | Redness | Chemosis | Discharge | ||
0.1 | 1 h | 0.7 (0-1) | 2.7 (0-4) | 0.8 (0-1) | 2.8 (2-3) | 2.8 (1-4) | 2.7 (1-3) |
4 h | 0.8 (0-1) | 2.8 (0-4) | 0.8 (0-1) | 2.5 (1-3) | 2.5 (1-3) | 2.5 (1-3) | |
1 day | 1.0 (0-2) | 2.7 (0-4) | 0.8 (0-1) | 2.0 (0-3) | 1.2 (0-2) | 1.5 (0-3) | |
2 days | 1.0 (0-2) | 2.3 (0-4) | 0.0 | 1.8 (0-3) | 0.8 (0-1) | 0.3 (0-2) | |
3 days | 0.8 (0-2) | 2.3 (0-4) | 0.2 (0-1) | 1.3 (0-2) | 0.5 (0-1) | 0.3 (0-2) | |
7 days | 0.2 (0-1) | 0.3 (0-2) | 0.0 | 0.0 | 0.2 (0-1) | 0 | |
14 days | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
0.01 | 1 h | 0.3 (0-1) | 0.8 (0-3) | 1.0 (1-1) | 2.8 (2-3) | 2.7 (2-3) | 2.7 (2-3) |
4 h | 1.3 (0-2) | 2.0 (0-4) | 1.0 (1-1) | 2.8 (2-3) | 2.8 (1-4) | 2.7 (1-3) | |
1 day | 1.5 (0-2) | 1.0 (1-2) | 0.8 (0-1) | 2.7 (2-3) | 1.3 (0-2) | 1.8 (0-3) | |
2 days | 1.5 (0-2) | 0.8 (0-1) | 0.5 (0-1) | 1.8 (0-3) | 1.2 (0-2) | 1.0 (0-2) | |
3 days | 0.7 (0-2) | 0.5 (0-1) | 0.5 (0-1) | 1.2 (0-2) | 1.2 (0-2) | 0.3 (0-1) | |
7 days | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
0.005 | 1 h | 0.7 (0-1) | 0.7 (0-1) | 0.5 (0-1) | 3.0 (3-3) | 2.3 (2-3) | 3.0 (3-3) |
4 h | 0.3 (0-1) | 0.3 (0-1) | 1.0 (0-1) | 3.0 (3-3) | 3.2 (2-4) | 3.0 (3-3) | |
1 day | 0.8 (0-1) | 0.8 (0-1) | 0.3 (0-1) | 2.5 (2-3) | 2.0 (2-2) | 1.3 (2-3) | |
2 days | 0.8 (0 -1) | 1.0 (0-2) | 0.0 | 1.5 (1-2) | 1.5 (1-2) | 0.7 (1-2) | |
3 days | 0.5 (0-2) | 0.3 (0-1) | 0.2 (0-1) | 0.8 (0-2) | 0.8 (1.2) | 0.7 (0-2) | |
7 days | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- Category I
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EHD causes severe eye damage when administered undiluted into the eyes of rabbits, which resolved within 7 days.
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