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EC number: 248-471-3 | CAS number: 27458-94-2
- 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
- Study period:
- 1986.04.22 - 1986.05.13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study essentially undertaken to standard eye irritation guidelines, although not to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Isononyl alcohol
- EC Number:
- 248-471-3
- EC Name:
- Isononyl alcohol
- Cas Number:
- 27458-94-2
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Isononanol
- Physical state: liquid
- Analytical purity: >99%
- Sample-No.: 3635-81058
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleine weisse Russen, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberbach
- Weight at study initiation: 2.2 - 3.0 Kg
- Housing: separately in stainless cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 1°C
- Humidity (%): 60% +- 5%
- Air changes (per hr): 15 times / hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1cm³ into the right eye. Left eye acted as an untreated control
- Duration of treatment / exposure:
- 72 hours.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 72 hours the treated eye was washed with warm physiological saline (NaCl-solution)
SCORING SYSTEM:
- In according to Draize (Appraisals of the Safety of chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas 1959 (page 51).
TOOL USED TO ASSESS SCORE:
- hand-slit lamp and "Na-Fluorescein"-Solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Iris reddened at 24 and 48 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (conjunctival redness)
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Remarks:
- (conjunctival oedema)
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Easily discernible opacity continued to Day 21
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Iris partly reddened at 24 hrs, white line on pupil Day 6 to 10 and circumcorneal injection to Day 21
- Irritation parameter:
- conjunctivae score
- Remarks:
- (conjuntival redness)
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Remarks:
- (conjunctival oedema)
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Iris reddened at 24, 48 and 72 hrs, partly reddened with circumcorneal injection Days 6-10
- Irritation parameter:
- conjunctivae score
- Remarks:
- (conjunctival redness)
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Remarks:
- (conjunctival oedema)
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Isononanol caused serious damage to the eye.
- Executive summary:
Isononanol (0.1 ml) was instilled into the right eye of three rabbits. Responses to treatment were assessed using the Draize method 1, 24, 48 and 72 hrs after instillation and again on Days 6, 8, 10, 14, 17 and 21. Easily discernible areas of corneal opacity, reddening of the iris and diffuse beefy-red and slight or obvious swelling of the conjunctivae were observed amonst all three animals.. Corneal opacity and reddening of the iris persisted in one animal on Day 21.
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