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Diss Factsheets
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EC number: 211-074-0 | CAS number: 629-11-8
- 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
- Study period:
- 16 Nov 2015 - 01 Dec 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexane-1,6-diol
- EC Number:
- 211-074-0
- EC Name:
- Hexane-1,6-diol
- Cas Number:
- 629-11-8
- Molecular formula:
- C6H14O2
- IUPAC Name:
- hexane-1,6-diol
- Details on test material:
- - Name of test material (as cited in study report): 1,6-Hexanediol
- Test-item No.: 13/0044-1
- Physical state: solid/colorless
- Analytical purity: 95.9 corr. area %
- Lot/batch No.: 000STD77L0
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Expiration date of the lot/batch: August 13, 2016
- Homogeneity: The test item was homogeneous by visual inspection
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.23 kg – 2.59 kg
- Housing: Single housing
- Diet: STANRAB (P) SQC; SDS special Diets Services, ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- For better handling the test item was heated at 45°C. The test item was heated for each test animal shortly before administration in addition to
stirring with a spatula and a magnetic stirrer. The homogeneity of the test item during administration was ensured by stirring with a magnetic stirrer The test item was administrated lukewarm. - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: after 24 hours of exposure
SCORING SYSTEM: according to the quoted guidelines
TOOL USED TO ASSESS SCORE: hand-slit lamp ans otoscope lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Reversibility:
- other: no effects on cornea observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Reversibility:
- other: no effects on iris obserded
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Reversibility:
- fully reversible within: 7days
Any other information on results incl. tables
No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours.
Moderate iritis (grade 1) was observed in two animals 1 hour after application only. All animals revealed slight conjunctival redness (grade 1) at hour 1 after application, which increased to moderate conjunctival redness (grade 2) at hour 24 and persisted in one of these animals until hour 48, followed by slight conjunctival redness (grade 1) at hour 72. The other two animals showed slight conjunctival redness (grade 1) from hour 48 until hour 72.
All animals showed moderate conjunctival chemosis (grade 2) at hour 1, which persisted in one of these animals until hour 24 and regressed to slight conjunctival chemosis (grade 1) at hour 48. The other two animals showed slight conjunctival chemosis (grade 1) from hour 24 until hour 72.
Obvious discharge (grade 2) was noted in all animals 1 hour after application and persisted in one of these animals until hour 24. The other two animals revealed slight discharge (grade 1) at hour 24.
Additional findings like desquamation of corneal epithelium and injected scleral vessels in a circumscribed or circular area were noted in the animals within 48 or 72 hours after application.
The ocular reactions were reversible in all animals within 7 days after application
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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