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EC number: 230-029-6 | CAS number: 6920-22-5
- 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:
- June - August 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- scientifically acceptable method was used and adequately reported, similar to OECD 405, no GLP, only 10 µL test item was administered, considered reliable with restrictions because results lead to classification and classification is identical to the chemically very similar 1,2-pentanediol
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Standard method for Evaluation of Eye Irritation in Albino Rabbits, E 1055-85, ASTM
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- DL-hexane-1,2-diol
- EC Number:
- 230-029-6
- EC Name:
- DL-hexane-1,2-diol
- Cas Number:
- 6920-22-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- hexane-1,2-diol
- Reference substance name:
- 1,2-hexanediol
- IUPAC Name:
- 1,2-hexanediol
- Test material form:
- other: colourless liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Adult, New Zealand Whlte rabbltw were received at SLS from Myrtle‘s Rabbitry, Thompson Station, TN. Upon receipt, plastic ear tags displaying
unique identication numbers were used to individually identity the animals. Cage cards displaying at least the study number, animal number and sex
were affixed to each cage. The animals were housed individually in suspended stainless steel cages. AlI housing and care were based on the
standards recommended by the Guide for the Care and Use of Laboratory Animals.
The animal room temperature and relave humidity ranges were 65-72 °F and 50-73%. respectively. Environmental control equipment was monitored
and adjusted as necessary to minimize uctuations in the animal room environment. Light timers were set to maintain a 12-hour light/12-hour dark
cycle and room ventilation was set to produce 10-15 airchanges per hour. The animal room temperature and relative humidity were recorded a minimum of once daily.
Animals were acclimated, water and food was controled and animal selection for test was performed randomly.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye of each animal used as control
- Amount / concentration applied:
- 100% concentration, 10 µl per animal eye
- Duration of treatment / exposure:
- Following macroscopic observations t the 24-hour scoring interval, the fluorescein examintion procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this time (if possible) with physiological saline.
- Observation period (in vivo):
- Any unusual observations or mortality were recorded. Mortality checks were performed twice dily, in the morning and afternoon. Scores were taken 1, 24, 48 and 72 hours following start of exposure as well as on days 4, 7, 10 and 14 when last score returned to 0.
- Number of animals or in vitro replicates:
- 3 animals (1 male and 2 females) were used for this experiment
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Other effects:
- Fluorescein retention was associated with the areas of corneal opacity. At 1 hour readings corneal epitelial tissue was observed to be peeling of the corneal surface.
Any other information on results incl. tables
Exposure to the test article produced corneal opacity in 3/3 test eyes at the1 -hourr scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The corneal injury resolved in all test eyes by study day 14. Iritis was observed in 3/3 test eyes at the 1 hour scoring interval and resolved in all test eyes by day 7. Conjunctivitis and chemosis was noted in 3/3 test eyes at the 1 -hour scoring interval. The effects resolved completely in all test eyes at study day 10.
No mortality was observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance 1,2-hexanediol was shown to be irritant to rabbit eyes in this test according to ASTM method E 1055-85.
- Executive summary:
Exposure to the test article produced corneal opacity in 3/3 test eyes at the1 -hourr scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The mean score for the 24, 48 and 72 hour scoring interval was 2 (max. score 4) and therefore qualifies this result as irritating to eyes, Category 2 according to CLP (Regulation (EC) No 1272/2008). The corneal injury resolved in all test eyes by study day 14. Iritis was observed in 3/3 test eyes at the 1 hour scoring interval and resolved in all test eyes by day 7. The mean score for the 24, 48 and 72 hour scoring interval was 0.89 (max. score 2).
Conjunctivitis and chemosis was noted in 3/3 test eyes at the 1 -hour scoring interval. The effects resolved completely in all test eyes at study day 10. The mean score for the 24, 48 and 72 hour scoring interval was 1.78 for conjunctivitis and chemosis (max. score 3 respectively 4)
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