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Diss Factsheets
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EC number: 947-976-2 | 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:
- 1978 June - October
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Test performed by nationally accredited lab with well-defined protocol.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Principles of method if other than guideline:
- - Principle of test:
Test substance was applied to the eyes of animals for 30 seconds. The animals were observed for ocular lesions at 24, 48, and 72 hours after instillation of test material.
- Short description of test conditions: Healthy rabbits received 0.1 ml of test material in one eye. Eyes were washed with 20 ml of distilled water for 30 seconds after instillation.
- Parameters analysed / observed: Lesions to the cornea, iris, and conjunctivae. Conjunctivae were evaluated for redness and chemosis. - GLP compliance:
- no
Test material
- Reference substance name:
- 2-hydroxyethyl ricinoleate
- EC Number:
- 203-369-8
- EC Name:
- 2-hydroxyethyl ricinoleate
- Cas Number:
- 106-17-2
- Molecular formula:
- C20H38O4
- IUPAC Name:
- 2-hydroxyethyl 12-hydroxyoctadec-9-enoate
- Reference substance name:
- 2,3-dihydroxypropyl 12-hydroxy-9-octadecenoate
- EC Number:
- 205-455-0
- EC Name:
- 2,3-dihydroxypropyl 12-hydroxy-9-octadecenoate
- Cas Number:
- 141-08-2
- Molecular formula:
- C21H40O5
- IUPAC Name:
- 2,3-dihydroxypropyl 12-hydroxyoctadec-9-enoate
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
NL Industries
- Expiration date of the lot/batch:
Lot # 60-8313-01
- Purity test date:
N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Not reported
- Stability under test conditions: Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle:
N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
N/A
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
Used as received
- Preliminary purification step (if any):
None
- Final dilution of a dissolved solid, stock liquid or gel:
N/A
- Final preparation of a solid:
N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material)
: 5000 mg/kg
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
: N/A
OTHER SPECIFICS:
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farms, Belvidere, New Jersey, USA
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Ad libitum Purina rabbit chow
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: To: Not reported
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of treatment / exposure:
- 30 s
- Observation period (in vivo):
- 72 hr (data recorded every 24 hr)
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): With and without irrigation with distilled water
- Time after start of exposure: 30 s
SCORING SYSTEM: Lesions to the cornea, iris, and conjunctivae. For the cornea, scores ranged from 0-4, with 0 being no ulceration or opacity, and 4 being complete corneal opacity with iris not discernible. For the iris, scores ranged from 0-2, with 0 being normal, and 2 being no reaction to light, hemorrhage, gross destruction, or all of the above. Lesions to the conjunctivae were scored separately for redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) and chemosis. For redness, scores ranged from 0-3, with 0 being normal vessels, and 3 being diffuse beefy red. For chemosis, scores ranged from 0-4, with 0 being no swelling, and 4 being swelling with lids more than half closed.
TOOL USED TO ASSESS SCORE: gross observation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- no wash
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- no wash
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- no wash
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 30
- Reversibility:
- fully reversible
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- no wash
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 30
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- no wash
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- wash
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.66
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Remarks:
- wash
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- wash
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was evaluated under the criteria defined by 16 CFR 1500.42 for eye irritation in vivo. While the test substance was determined to be an ocular irritant by these criteria, it does not meet the criteria of Regulation EC No. 1272/2008 for classification of eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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