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Diss Factsheets
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EC number: 948-056-3 | 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HET CAM
- Principles of method if other than guideline:
- The test was based on the observation, by a trained person, of the irritant effects (hyperhemia, hemorrhage and coagulation) occuring during the five minutes after application of the product to the chorioallantoic membrane (CAM) of embryonic hen's eggs on the tenth day of incubation.
The irritant potential was scored according to a scale from 0 to 21. The product was classified in one of the categories defined according to the mean score obtained.
Different concentrations of the test product are used in the assay in order to determine the
amount inducing a 50% réduction in the NRR (IC50, inhibition concentration 50).
An in vitro/in vivo correlation matrix between the IC50 determined in the PREDISAFE assay
and the Draize irritation data, allows the assessment of the ocular tolerance of the test product (Guyomard et al., 1994) - GLP compliance:
- not specified
Test material
- Reference substance name:
- Olive oil decyl esters
- EC Number:
- 948-056-3
- IUPAC Name:
- Olive oil decyl esters
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Tested at the use concentration of 100%
Test animals / tissue source
- Species:
- other: Embryonic Hen's ,eggs
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- Eggs were graded between 50 and 65 g.
Eggs were identified and put into an incubator, under controled conditions of temperature (37.8°C + 0.5°C) and relative humidity (50 to 60 %).
Eggs were incubated, either in an incubator with oscillating plates (in vertical position), or in an incubator with manual reversal. In tins case, eggs were turned over three times a day and were put in vertical position (air pocket upwards) on the 8th day of incubation.
Test system
- Amount / concentration applied:
- 1 concentration tested : 100%
- Duration of treatment / exposure:
- 20 seconds
- Duration of post- treatment incubation (in vitro):
- 5 minutes of observation
- Number of animals or in vitro replicates:
- 4 eggs
- Details on study design:
- 1)Tested product conditions of use
The product was tested as such.
The product was brought at 37°C before use.
2) preparation of eggs
The different steps of the study were performed quickly under a constant lighting which did not give out too much heat in order to avoid the withering of the chorioallantoic membrane.
On the 10th day of incubation, eggs were taken out of the incubator one by one and were candled with a lamp. The defective eggs (image which did not correspond to the expected stage of development) were eliminated and the selected eggs were put on the holder, « air pocket » upwards.
The shell of the each selected egg was drilled (with a lanceolate needle) and cut up (with scissors with blunt ends or forceps) at air pocket level and until the limits of the shell membrane.
Then the whole surface of the shell membrane was moistened with a 0.9 % sodium chloride solution, warmed up at 37°C (bain-marie). Then, the excess of 0.9 % sodium chloride solution was eliminated by tilting of the egg and the shell membrane was removed delicately with forceps in order to uncover the underlying CAM.
Any egg whose chorioallantoic membrane was damaged (tear, presence of hemorrhage and any other lesion) was immediately rejected.
3) Application of the tested product
The product was tested on 4 eggs.
300 µL were deposited on the CAM, with a micropipette (P1000). lmmediately after application, the chronometer was set off.
4)Readings
After 20 seconds' contact, the CAM was rinsed with 10 to 20 ml of sodium chloride isotonic solution (kept at 37°C in bain-marie), with a syringe avoiding any brutal projection.
The rinse liquid was eliminated by tilting of the egg.
The possible phenomena of irritation were observed during 5 minutes according to the process described in the following paragraph. The accurate rime of each phenomenon appearance was noted.
The 20 seconds' contact were included in the 5 minutes' observation.
At the end of the study, embryos were destroyed by quick cooling (enclosure at -20°C).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Hyperhemia
- Value:
- ca. 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation parameter:
- other: Hemorrhage
- Value:
- ca. 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation parameter:
- other: Coagulation
- Value:
- ca. 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Executive summary:
The test substance was judged weakly irritating for the embryonic hen's egg chorioallantoic membrane and therefore is expected to be weakly irritating to the eye.
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