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EC number: 814-233-8 | CAS number: 444649-70-1
- 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:
- From May 14, 2001 to May 25, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Molecular formula:
- C16H28O5
- IUPAC Name:
- Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Reference substance name:
- Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Molecular formula:
- C17H30O5
- IUPAC Name:
- Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Reference substance name:
- glycerol 1,3-dineodecanoate
- Molecular formula:
- C23H44O5
- IUPAC Name:
- glycerol 1,3-dineodecanoate
- Reference substance name:
- Sum of other constituents, each of them at <1%
- Molecular formula:
- Not available
- IUPAC Name:
- Sum of other constituents, each of them at <1%
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Batch no.: F016143 05
Appearance: Light-yellow, clear viscous liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Charles River Wiga, D-97633
Acclimatization: 5 days
Body weight: 2.1-2.3 kg
Temperature: ca. 20.3°C, relative humidity : ca. 58.8% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin 2123, ad libitum
Water: tap water for human consumption, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- one application
- Observation period (in vivo):
- 1, 24, 48 and 72h after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent loss of the test substance. The left eyes remained untreated and served as a control.
- Both eye were examinated within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examinated using an otoscope lamp.
- Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score.
- In addition, the animals were observed for other than local changes at all observation times. Body weights were rmeasured at the start and at the end of the test. Genral signs of toxicity were recorded once daily.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test.
- Other effects:
- No general toxic effects of the test substance were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the test substance was considered not irritating to rabbit eye.
- Executive summary:
An in vivo study was conducted to determine the eye irritation of the test substance according to OECD Guideline 405, EU Method B.5 and EPA OPPTS 870.2400, in compliance with GLP. 0.1 mL of the test substance was administered per rabbit (New-Zealand White females) into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The left eyes remained untreated and served as a control. Both eye were examined within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examined. Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score. In addition, the animals were observed for other than local changes at all observation times. Body weights were measured at the start and at the end of the test. General signs of toxicity were recorded once daily. No general toxic effects of the test substance were observed. All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test. Under the study conditions, the test substance was considered not irritating to rabbit eye (Wolf, 2001).
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