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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
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EC number: - | 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:
- From 3 Jan 2022 to 13 January 2022
- Reliability:
- 1 (reliable without restriction)
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 (incl. QA statement)
Test material
- Reference substance name:
- Heavy wax residue fraction, waste plastic derived, hydrothermal conversion
- Molecular formula:
- Not applicable - UVCB
- IUPAC Name:
- Heavy wax residue fraction, waste plastic derived, hydrothermal conversion
- Test material form:
- other: solid - lumps
- Details on test material:
- - Stability: stable under storage conditions
- Storage: room temperature (20 ± 5 °C)
- Appearance: large, brown, solid lumps
- Purity: not applicable, UVCB
- Homogeneity: homogeneous
- EC no.: 950-445-8
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcularTM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm2.
EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories, Mlynské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-200-EACH
Day of delivery: 11. Jan. 2022
Batch no.: 34948
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The solid, wax-like test item was grated with a square grater to achieve most possible shredding and fine test item fragments.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Amount test item:
Tissue 1: 51.0 mg
Tissue 2: 51.3 mg - Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2 replicates for test item, negative control and positive control
- Details on study design:
- Study was performed according to the guideline.
Doses used: 50 µl of controls, 51.0 mg and 51.3 mg of test item
Demonstration of proficiency:
The validity of the EpiOcularTM test at LAUS GmbH was demonstrated in a non-GLP profi-ciency study. For this purpose 15 proficiency chemicals (indicated by the OECD 492 guide-line) were tested. All of the 15 proficiency chemicals were correctly categorized. Therefore, the proficiency of the EpiOcularTM test was demonstrated.
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- Mean of tissue 1 and 2
- Value:
- 98.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, Heavy wax residue fraction, waste plastic derived, hydrothermal conversion is considered non-eye irritant (GHS No Category) in the Epi-OcularTM Eye Irritation Test.
- Executive summary:
The test item Heavy wax residue fraction, waste plastic derived, hydrothermal conversion was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours.
The solid test item was applied to two tissue replicates.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The form-azan production was evaluated by measuring the optical density (OD) of the resulting solu-tion.
Demineralized water was used as negative control and methyl acetate was used as positive control.
The controls showed the following results: After treatment with the negative control, the ab-sorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.8, OD was 1.786. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 29.5% (< 50%).
The variation within tissue replicates of the controls and the test item was acceptable (< 20%).
After treatment with the test item, the mean value of relative tissue viability was 98.7 %.
This value is above the threshold for eye irritation potential (≤ 60%). Test items that induce values above the threshold are considered non-eye irritant.
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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