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EC number: 239-555-0 | CAS number: 15520-05-5
- 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, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-(octylimino)bisethanol
- EC Number:
- 239-555-0
- EC Name:
- 2,2'-(octylimino)bisethanol
- Cas Number:
- 15520-05-5
- Molecular formula:
- C12H27NO2
- IUPAC Name:
- 2-[(2-hydroxyethyl)(octyl)amino]ethan-1-ol
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- details on strain: Chbb: NZW (SPF)
origin of test animal: Chemisch pharmazeutische Fabrik; Dr. Karl Thomae GmbH, 88400 Biberach; Germany; SPF-Zucht
age of test animals: 3 - 5 months
weight of test animal: 3.4 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL of the undiluted test item was applied
- Duration of treatment / exposure:
- once applied into conjunctival sac of left eye; 24 hours after treatment and at any time point when the cornea needs to be inspected with fluorescein-sodium solution, the eye was washed with physiological saline solution (Temperature about 37°C).
- Observation period (in vivo):
- evaluation of the treated eye was performed after:
1 h, 24 h, 48 h, 72 h and 7 days - Number of animals or in vitro replicates:
- 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1-3 days
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Seven days after the application of test item the cornea showed diffuse opacity areas and additional an advanced vascularization was observed.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1-3 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1-3 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: Until 72 hours after application the conjunctiva showed a crimson up to diffuse strong red color and an edema up to half eye-lid closure
- Remarks on result:
- other: Seven days after the application of test item the conjunctiva showed still a diffuse crimson color
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1-3 days
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be highly eye irritant.
- Executive summary:
In order to assess the eye irrtating potential of the test substance, 0.1 mL of the undiluted test item was applied into the conjunctival sac of the left eye of one rabbit. The untreated eye serves as control. 24 hours after treatment and at any time point when the cornea needs to be inspected with fluorescein-sodium solution, the eye was washed with physiological saline solution (Temperature about 37°C). The assessment was performed 60 minutes, 24, 48 and 72 hours after application of test item and additionally after 7 days due to some findings. At the 24 and 72 hour time point and after 7 days, additionally a drop of fluorescein-sodium solution was instilled and the eye was examined under UV-light. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation, the presence of serious lesions and non-occular effects were noted.
Until 72 hours after application the conjunctiva showed a crimson up to diffuse strong red color and an edema up to half eye-lid closure. The iris was reddened. The cornea showed diffuse to pearly-like opacity areas. Additional a clear-colorless or white to mucous effluent and bleeding of the nictitating membrane was observed. Seven days after the application of test item the conjunctiva showed still a diffuse crimson color and the cornea diffuse opacity areas. Additional an advanced vascularization was observed.
Based on the findings of this OECD 405 study in New Zealand White rabbits, the test substance is determined to be highly eye irritant.
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