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EC number: 234-764-3 | CAS number: 12032-20-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2016-09-21 to 2017-07-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 6 July 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin(TM) SOP, ECVAM Skin Irritation Validation Study: Validation of the EpiSkin(TM) test method 15 min - 42 h for the prediction of acute skin irritation of chemicals
- Version / remarks:
- February 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lutetium oxide
- EC Number:
- 234-764-3
- EC Name:
- Lutetium oxide
- Cas Number:
- 12032-20-1
- Molecular formula:
- Lu2O3
- IUPAC Name:
- Lutetium oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): dilutetium trioxide
- Physical state/Appearance: white solid
- Further information confidential.
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied as supplied, no formulation was required.
OTHER:
- Correction factor: No correction for purity of the test item was applied.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified (adult)
- Source strain:
- other: not applicable
- Justification for test system used:
- The EPISKIN TM (SM) model has been validated for irritation testing in an international validation study and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439). Therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN TM (SM) (Manufacturer: SkinEthic, France)
- Tissue batch number(s): 16-EKIN-038 (expiry date: 26 September 2016) used in Experiment I and 16-EKIN-040 (expiry date: 10 October 2016) used in Experiment II
- Date of initiation of testing: 21 September (Experiment I) and 5 October 2016 (Experiment II)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 23.2-25.9°C in Experiment I, 23.3-24.8°C in Experiment II
- Temperature of post-treatment incubation (if applicable): 37°C ± 1.0°C
- All incubations were carried out in a humid atmosphere (> 95%) containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C. Temperature and humidity were continuously monitored once on each working day. Temporary deviations from the temperature, humidity and CO2 percentage may occur due to opening and closing of the incubator door. Any variation to these conditions were evaluated and maintained in the raw data.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: After the 15 minutes incubation time, the EPISKIN (SM) units were removed and rinsed thoroughly with phosphate buffered saline (PBS) to remove any remaining material from the epidermal surface as much as possible. The rest of the PBS was removed from the epidermal surface with a pipette (without touching the epidermis).
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: yes, plate reader, not further specified
- Wavelength: 570 nm
- Prior to treatment, the test item was evaluated for its intrinsic colour or ability to become coloured in contact with water (simulating a tissue humid environment). As the test item had an intrinsic colour, further evaluation to detect colouring potential was necessary. Non Specific Colour % (NSCliving %) was determined in order to evaluate the ability of the test item to stain the epidermis by using additional control tissues.
Therefore, in addition to the normal procedure, two additional test item-treated living tissues were used for the non-specific OD evaluation. This tissue followed the same test item application and all steps as for the other tissues, except for the MTT step: MTT incubation was replaced by incubation with fresh Assay Medium to mimic the amount of colour from the test item that may be present in the test disks. OD reading was conducted following the same conditions as for the other tissues.
NUMBER OF REPLICATE TISSUES: 5 for the test item, 3 for negative controls and 3 for positive controls
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test item is considered to be non-irritant to skin if the mean relative viability of three individual tissues after 15 minutes exposure to the test item and 42 hours post incubation is more than 50% of the mean variability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
NEGATIVE CONTROL (Phosphate Buffered Saline)
- Amount(s) applied (volume or weight): 50 μL
POSITIVE CONTROL (Sodium Dodecyl Sulphate solution)
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 minutes (± 0.5 min)
- Duration of post-treatment incubation (if applicable):
- 42 hours (± 1 h)
- Number of replicates:
- 5 replicates for the test item, 3 negative controls and 3 positive controls
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 3 replicates, experiment I
- Value:
- 93
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: As the test item was coloured, two additional test item-treated tissues were used for the non-specific OD evaluation (experiment II). The mean optical density (measured at 570 nm) of these two tissues was 0.005. Non Specific Colour % was calculated to be 0.6%. This value was below 5%, therefore additional data calculation was not necessary.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The mean OD value of the three negative control tissues was in the recommended range (0.854 in Experiment I and 0.764 in Experiment II). Standard deviation of the viability results for negative control samples was 14.0 in Experiment I and 6.8 in Experiment II.
- Acceptance criteria met for positive control: Yes. The three positive control treated tissues showed 3.8% (Experiment I) and 5.3% (Experiment II) viability demonstrating the proper performance of the assay. The standard deviation of the viability results for positive control samples was 1.2 in Experiment I and Experiment II.
- Acceptance criteria met for variability between replicate measurements: Yes. The standard deviation of viability values of the five test item-treated tissue samples in the MTT assay was 10.7.
- The mean OD value of the blank samples (acidified isopropanol) was 0.048 in Experiment I and 0.045 in Experiment II.
All these parameters met the acceptability criteria, therefore the study was considered to be valid.
Any other information on results incl. tables
Optical Density (OD) and the calculated relative viability % of the samples (Experiment 1)
Optical Density (OD) |
Viability |
|||
Substance |
Measured |
Blank Corrected |
% RV |
|
Negative Control: | 1 | 0.884 |
0.835 |
97.8 |
Phosphate Buffered saline | 2 | 0.794 |
0.745 |
87.2 |
3 | 1.031 |
0.982 |
115.0 |
|
Mean | ---- |
0.854 |
100.0 |
|
Positive Control: | 1 | 0.070 |
0.021 |
2.5 |
5% (w/v) SDS solution | 2 | 0.087 |
0.039 |
4.5 |
3 | 0.087 |
0.038 |
4.5 |
|
Mean | ---- |
0.033 |
3.8 |
|
Test Item: | 1 | 0.709 |
0.660 |
77.3 |
Dilutetium trioxide | 2 | 0.837 |
0.788 |
92.3 |
3 | 0.966 |
0.917 |
107.4 |
|
4 | 0.840 |
0.791 |
92.6 |
|
5 | 0.863 |
0.815 |
95.4 |
|
Mean | ---- |
0.794 |
93.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study (in vitro EPISKIN model test according to OECD guideline 439), the test item was determined to be non-irritant to skin. Based on these results, the test item is considered not classified according to the CLP Regulation.
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