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EC number: 268-793-8 | CAS number: 68140-41-0
- 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:
- 5th October 2017- 19th October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)
- EC Number:
- 268-793-8
- EC Name:
- Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)
- Cas Number:
- 68140-41-0
- Molecular formula:
- C18H34O2.C4H11NO
- IUPAC Name:
- oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)
Constituent 1
Test animals / tissue source
- Species:
- guinea pig
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The study was conducted using Female New Zealand White Rabbits ten to twelve weeks old. The rabbits were obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 2.20 to 2.59 kilograms at the start of the study and were individually housed in stainless steel cages in a temperature (63-73°F), humidity (30-70%), and light controlled room. Each rabbit was assigned a test animal number which appeared on a cage card visible on the front of each cage. The females were nulliparous and non-pregnant. The rabbits were maintained according to the recommendations contained in the National Academy Press 2011: "Guide for the Care and Use of Laboratory Animals". They were conditioned for at least five days prior to study initiation. Purina Rabbit chow and water were available ad libitum. All animals used for this study were considered to be in good health at the study initiation.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 0.1 ml of the test substance was instilled into the one eye and then holding the eye lids together for one second to prevent loss of the material
- Observation period (in vivo):
- 24 hours
- Details on study design:
- 24 hours before the start of the study both eyes of the experimental animals were examined for pre-existing ocular lesions. Only those animals with no pre-existing ocular lesions were used for test purposes. Five minutes prior to dosing, the eyes were anesthetized with Tetracaine HCL solution. Three animals were dosed by instilling 0.1 ml of the test article into one eye and then holding the eye lids together for one second to prevent loss of the material. The contralateral eye
served as the untreated control for each rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 14days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 7days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 14days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Following exposure of test substance to the eye of rabbits, there was severe irritation observed in all of the test subjects. The calculated mean score following grading at 24, 48 and 72 hours after installation of the test material, 3 animals showed positive responses of cornea opacity≥1, Iris ≥1, and conjunctival redness ≥2, while 2 animals showed positive response of conjunctival chemosis ≥2. All responses observed clear within 14days observation. Therefore, in accordance with the CLP guidance, the test substance meet the classification criteria for eye irritation and would be classified as H319; Causes serious eye irritation.
- Executive summary:
The test substance was tested for eye irritation in accordance with OECD Guidelines (405). The test substance, a viscous paste was administered into one eye of each of three albino rabbits. The eyes were observed and scored at 1, 24, 48, 72,168 and 336 hours. There was severe irritation observed in all of the test subjects. Following exposure of test substance to the eye of rabbits, there was severe irritation observed in all of the test subjects. The calculated mean score following grading at 24, 48 and 72 hours after installation of the test material, 3 animals showed positive responses of cornea opacity≥1, Iris ≥1, and conjunctival redness ≥2, while 2 animals showed positive response of conjunctival chemosis ≥2. All responses observed clear within 14days observation. Therefore, in accordance with the CLP guidance, the test substance meet the classification criteria for eye irritation and would be classified as H319; Causes serious eye irritation.
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