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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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- 8th 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:
- Sebacic acid, compound with 2-aminoethanol (1:2)
- Molecular formula:
- C10H18O4.2(C2H7NO)
- IUPAC Name:
- Sebacic acid, compound with 2-aminoethanol (1:2)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The Study was conducted using rabbits obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 2.74 to 2.83
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:
- 0.1ml
- Duration of treatment / exposure:
- The test article was ground into a fine powder prior to dosing and 0.1 ml packed volume was instilled into one eye 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 - Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- 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. The test article was ground into a fine powder prior to dosing and the powdered
test article was used for dosing. Five minutes prior to dosing, the eyes were anesthetized with
Tetracaine HCL solution. Three animals were dosed by instilling 0.1 ml. packed volume 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:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no observed effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no observed effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no observed effect
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no observed effect
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was instilled into the eyes of rabbits and the eyes were observed and scored at 1, 24, 48 and 72 hours. There were minimal eye irritation reactions in all of the test subjects which cleared by the 1 hour observation. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for eye irritation.
- Executive summary:
The test substance potential to induce eye irritation was conducted in the OECD guidelines 405. 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.The test substance was instilled into the eyes of rabbits and the eyes were observed and scored at 1, 24, 48 and 72 hours. The eyes were examined at 1, 24, 48 and 72 hours after treatment. There were minimal eye irritation reactions in all of the test subjects which cleared by the 1 hour observation. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for eye irritation.
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