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EC number: 214-254-7 | CAS number: 1117-86-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to an internationally accepted technical guideline and in compliance with GLP in a recognized contract research organization.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- of 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octane-1,2-diol
- EC Number:
- 214-254-7
- EC Name:
- Octane-1,2-diol
- Cas Number:
- 1117-86-8
- Molecular formula:
- C8H18O2
- IUPAC Name:
- octane-1,2-diol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species, Strain: Rabbits, New Zealand White (SPF Crl:NZW)
- Source: Charles River Wiga GmbH, D-97320 Sulzfeld, Germany
- Number and Sex: 2 males
- Age on day of dosing (Day 1): > ca. 3 months
- Weight prior to dosing (Day 1): Minimum 3790 g and 4545 g
- Housing: Individual housing in stainless steel cages (50 x55 x40 cm) with ovally peforated floor
- Bedding: ALTROMIN Type S8/15, granulated soft wood bedding
- Diet (ad libitum): Standard diet for rabbits (Brand: "ALTROMIN 2123"; Altromin, 32791 Lage/Lippe, Germany)
- Water(ad libitum): Tap water (municipal supply), in Makrolon® bottles, changed daily
- Acclimation period: Ca. 3 months prior to study start under laboratory conditions.
Routine analysis of the batch of diet used for nutrients and possible contaminants (heavy metals, aflatoxins, pesticides) and of the drinking water and bedding material for microbial contaminants, heavy metals and halogenated hydrocarbons were conducted or available at the testing facility.
ENVIRONMENTAL CONDITIONS
Air conditioned animal room set at:
- Temperature (°C): 21.5 to 22.5°C
- Relative Humidity (%): 40 to 70%
- Photoperiod: 12 hours artificial light, 12 hours dark per 24 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of the undiluted liquid test material was administered into the conjunctival sac of one eye per rabbit. The contralateral eye remained untreated to serve as a control.
- Duration of treatment / exposure:
- The treated eyes of both animals were carefully rinsed with deionised water at 1 hour after test material instillation, because of conjunctival redness and chemosis, grade 1 and 2, respectively. At 24 h after test material instillation, the treated eye of animal #1 was rinsed again, because of corneal opacity grade 2 in this eye.
- Observation period (in vivo):
- animal #1: 16 days
animal #2: 14 days - Number of animals or in vitro replicates:
- 2 male rabbits
- Details on study design:
- EYE EVALUATION:
Before treatment start both eyes of each animal were investigated after instillation of 2 or 3 drops of fluorescein sodium solution (0.5% in deionised water) into the conjunctival sac, to ensure that there were no pre-existing ocular defects. After 30 seconds the eyes were rinsed with deionised water.
One animal was initially treated and, in view of corneal opacity up to grade 2 and iridic swelling grade 1 for a number of days in this animal (#1), only one other animal (#2) was committed to the study for confirmation of the initial results 13 days afterwards.
Eyes were evaluated in both animals at approximately 1, 24, 48 and 72 hours after test material instillation adopting the numerical scoring system listed in Table 1 in the field below. Additional examinations were performed daily thereafter ending 16 and 14 days after test material instillation in animals #1 and #2, respectively. Grades attained at 48, 72 and 96 hours after instillation were included in the mean gradings of ocular lesions. Staining with fluorescein sodium solution supported the recognition of corneal lesions in animal #1 at 6 & 9 days after test material instillation and in #2 at 6, 8, 10 & 14 days after test material instillation.
Equipment used for eye evaluation: Hand slit-lamp (Heine OPTOTECHNIK)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 16 days
- Remarks on result:
- other: A lesion of the superficial epithelium of the cornea, ca. 3 mm diameter, was seen from Day 5 to Day 8 after test material instillation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: A lesion of the superficial epithelium of the cornea, ca. 3 mm diameter, was seen from Day 5 to Day 8 after test material instillation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: associated with iridic swelling and/or circumcorneal hyperaemia in the iris, and on a number of days with an oval pupil
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: associated with iridic swelling and/or circumcorneal hyperaemia in the iris, and on a number of days with an oval pupil
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: associated with iridic swelling and/or circumcorneal hyperaemia in the iris, and on a number of days with an oval pupil
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: associated with iridic swelling and/or circumcorneal hyperaemia in the iris, and on a number of days with an oval pupil
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Corneal lesions, grade 1 or 2 in animal #1 and grade 1 in #2 were seen from 1 hour (Day 0) or 24 hours after test material instillation (Day 1) and had entirely disappeared by Day 16 in animal #1 and by Day 14 in animal #2. On a number of consecutive days, a lesion of the superficial epithelium of the cornea, ca. 3 mm in diameter, was recorded in each animal.
Swelling of the iris (grade 1) was evident in animal #1 from 48 hours until 11 days after test material instillation and in animal #2 from 1 hour until 8 days after instillation and associated with circumcorneal hyperaemia in the iris in animal #1 for 5 days and animal #2 for 4 days. The observation of an oval appearance of the pupil seen on a number of days in each animal was considered to be related to iris swelling.
In addition to the findings specified above and under "Overall irritation/corrosion results", conjunctival redness grade 1 and chemosis grade 2 followed by grade 1 were also seen in both animals at 1 and 24 hours after instillation, and on some occasions, mucous secretion from the eye was recorded.
All ocular findings seen in the present study were fully reversible. Control eyes (untreated) were without ocular findings throughout the observation period. - Other effects:
- Mortality or signs of systemic toxicity were not evident and bodyweight was unaffected by treatment with the test material.
Applicant's summary and conclusion
- Interpretation of results:
- other: irritating to eyes
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