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Diss Factsheets
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EC number: 924-751-7 | 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
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- sunflower oil (Helianthus annuus L.), reaction products with ozone
- EC Number:
- 924-751-7
- IUPAC Name:
- sunflower oil (Helianthus annuus L.), reaction products with ozone
Constituent 1
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Value:
- > 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the experimental conditions and according to the results, the test item OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL) does not require classification for eye irritation or serious eye damage (GHS no category).
- Executive summary:
The purpose of the test is to identify chemical substances that do not require classification for eye irritation or serious eye damage (No Category) or requiring classification for eye irritation (Category 2) or requiring classification for serious eye damage (Category 1) according to the UN GHS hazard classification system. The procedure is carried out based on the method described in the OECD 492 guideline. This test makes use of commercially available three-dimensional RICE tissues that are produced using human immortalized corneal epithelial cells (SkinEthic't" HCE).
The evaluation of cell survival after three different time exposures to the substance is made by MIT assay, a colorimetric assay that is based on the ability of the mitochondrial succinate dehydrogenase enzyme of metabolic active cells, to reduce a yellow tetrazolium salt (MIT) to purple formazan crystals, that can be measured by spectrophotometer reading.
Chemicals substances not requiring classification and labeling according to UN GHS (No Category) are identified as those that do not decrease tissue viability below a defined threshold (50%) at all time treatments. Instead, chemicals substances are identified inducing serious eye damage (UN GHS Category 1) if the mean percent tissue viability after exposure is less than or equal to the established percentage (50%) at all time treatments. Chemicals substances are identified as chemical inducing eye irritation according to UN GHS (Category 2) if the combination of mean percent tissue viability within all time treatment fall outside of the criteria established to identify the test chemical as a No Category or Category 1.
The test item "OZONIA 3000 SUNFLOWER (OZONIZED SUNFLOWER SEED OIL)" in the experimental conditions here described, showed a mean cell survival of 98.6% (14.3) after 5 minutes treatment, of 102.9% (±8.9) after 16 minutes treatment and of 102.6% (13.8) after 2 hours treatment. These results suggest that test item DOES NOT REQUIRE CLASSIFICATION FOR EYE IRRITATION OR SERIOUS EYE DAMAGE (UN-GHS — No Category), because its cell viability is higher than 50% at all time treatments.
The positive control Methyl acetate showed a mean cell viability of 27.6% (10.8) after 5 minutes treatment, of 91.1% (t1.7) after 16 minutes treatment and of 97.6% (19.0) after 2 hour treatment. These results are keeping with the acceptance criteria required for the positive control. All other acceptance criteria were met, therefore the test can be considered qualified.
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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