Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-270-8 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984-05-30 - 1984-06-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted study similar to guideline (limited documentation, no specification on washing, scoring system in percentage of maximal possible reaction, 48 hours observation period)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation, not specification on washing, scoring system in percentage of maximal possible reaction, 48 hours observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- EC Number:
- 309-832-1
- EC Name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- Cas Number:
- 101227-09-2
- IUPAC Name:
- 101227-09-2
- Details on test material:
- - Name of test material (as cited in study report): Isohexadecylstearat
No further details provided
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 4420 g
No additional details provided.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Not specified (contact period was reported to be 10 s)
- Observation period (in vivo):
- 48 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
SCORING SYSTEM: the irritation (cornea, iris, conjuctivae) reaction were scored in percentage of the maximal possible reaction, but no discrimination was done for conjunctivae reaction (swelling or redness).
The results are therefore evaluated in a worst case approach, by attributing the full reported reactions (percentages, as described above) equally to conjunctivae redness and to conjunctivae swelling. The percentages will be converted to the OECD guideline scores as follows: 1) for conjunctivae redness, up to 100% will be considered to correspond to a OECD score of 3, up to 66% to 2 and up to 33% to 1); for conjunctivae swelling, up to 100% will be considered to correspond to a swelling score of 4, up to 75% to 3, up to 50% to 2, and up to 25% to 1.
TOOL USED TO ASSESS SCORE: not specified.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24-48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24-48 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- other: 24-48 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Original values: 36.5% of the maximal possible conjunctivae reaction (not specified if redness or swelling) was observed 1 hour after treatment, 20.0% 6 hours after treatment, 3.5% 24 hours after treatment, and 0% 48 hours after treatment.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24-48 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Original values: 36.5% of the maximal possible conjunctivae reaction (not specified if redness or swelling) was observed 1 hour after treatment, 20.0% 6 hours after treatment, 3.5% 24 hours after treatment, and 0% 48 hours after treatment.
- Irritant / corrosive response data:
- Neither cornea nor iris reactions were observed up to the end of the observation period. A moderate conjunctivae reaction was observed from 1 hour after treatment, but was completely reversible within 48 hours observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.