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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:
- 4 Mar 1988 - 11 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 1987)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 2002)
- Deviations:
- yes
- Remarks:
- Use of 4 animals and no data on purity of test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Sex: male
- Age at study initiation: adult
- Weight at study initiation: 2.42 kg (mean)
- Housing: single housing
- Diet: Altromin diet 2023, Altromin GmbH, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM:
Draize scheme
READINGS:
1, 6, 24, 48, and 72 hours after application
TOOL USED TO ASSESS SCORE:
fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Conjunctivae findings were observed at 1, 6, and 24 h after treatment. 3/4 animals had a score of 1, 1/4 animals had a score of 2 after 1 hour. After 6 h 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed no eye irritating potential
- Executive summary:
In a study according to OECD TG 405 (adopted 1987, GLP), the eye irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. 0.1 mL of the undiluted test substance was instilled into the rabbits eye and no washing was performed. Readings were performed 1, 6, 24, 48, and 72 hours after application. Conjunctivae findings were observed at 1, 6, and 24 h after treatment, where 3/4 animals had a score of 1 and 1/4 animals had a score of 2 after 1 hour. After 6 h, 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.
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