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EC number: 233-801-0 | CAS number: 10361-92-9
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11 August 2016 - 17 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 Bis (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Yttrium chloride hexahydrate
- Cas Number:
- 10025-94-2
- Molecular formula:
- YCl3.6H2O
- IUPAC Name:
- Yttrium chloride hexahydrate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of the test material (as cited in the report): yttrium trichloride hexahydrate
- Physical state: solid
- Appearance: white to yellowish crystalline powder
- Further information on test material confidential.
Constituent 1
- Specific details on test material used for the study:
- 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 (SM) model has been validated for corrosivity testing in an international trial (Fentem, 1998) and its use is recommended by the relevant OECD guideline for corrosivity testing (OECD No. 431). 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) (0.38 cm²), SkinEthic, France
- Tissue batch number(s): 16-EKIN-032
- Expiry date: August 15, 2016
- Date of initiation of testing: August 11, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 24.2-25.3°C
- Temperature of post-treatment incubation (if applicable): 37.0°C
- All incubations were carried out in a humid atmosphere (80-100%) 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 incubation time, the test item treated tissues or also the positive control tissues were removed and rinsed thoroughly with phosphate buffered saline (PBS) to remove all the remaining test or positive control material from the epidermal surface. Likewise, negative control tissues were processed accordingly. The rest of the PBS was removed from the epidermal surface using 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
NUMBER OF REPLICATE TISSUES: 2
ADDITIONAL CONTROL TISSUES
- No additional control tissues were used for direct interference with MTT as there was no indication of direct interference during a preliminary experiment.
- As the test item had an intrinsic colour, two additional test item-treated living tissues were used for the non-specific OD evaluation. These tissues 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 readings were conducted following the same conditions as for the other tissues.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
For 2 disks:
If both disks have mean viability of ≥ 35% = Non Corrosive
If both disks have mean viability of < 35% = Corrosive (at the corresponding incubation period)
Otherwise:
If the mean value is ≥ 35% and the variability is less than 50% = Non Corrosive
If the mean value is < 35% and the variability is less than 50% = Corrosive
VALIDITY OF THE TEST
- The mean OD value of the two negative control tissues should be ≥ 0.6 and ≤ 1.5 and negative control OD values should not be below historically established boundaries.
- The acceptable mean viability % range for positive control is ≤ 20%.
- The difference of viability between the two tissue replicates should not exceed 30%.
- The mean OD value of the blank samples (acidified isopropanol) should be < 0.1. - 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 (100 μL physiological saline was added to the test item to ensure good contact with the epidermis)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 0.9% (w/v)
- Lot/batch no. (if required): 52532Y05-2
- Expiry date: 31 May 2018
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): no data
- Lot/batch no. (if required): 15A160011
- Expiry date: 30 November 2017 - Duration of treatment / exposure:
- 4 hours (± 10 min)
- Number of replicates:
- 2 per group (test item, positive control, negative control)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 2 replicates
- Value:
- 86.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: range: 85.4 to 88.0%
- 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 living tissues were used for the non-specific OD evaluation. The mean optical density (measured at 570 nm) of these tissues was determined to be 0.003 and Non Specific Colour % (NSCliving%) was calculated as 0.4%. This is below the threshold of 5%, therefore correction due to colouring potential was not necessary.
VALIDITY OF THE TEST
After receipt, the two indicators of the delivered kits were checked. Based on the observed colours, the epidermis units were in proper conditions in each case.
The mean OD value of the two negative control tissues was in the recommended range (0.917).
The two positive control treated tissues showed 0.6% viability demonstrating the proper performance of the assay.
The difference of viability between the two test item-treated tissue samples in the MTT assay was 3.0%.
The mean OD value of the blank samples (acidified isopropanol) was 0.047.
All these parameters were within acceptable limits and therefore the study was considered to be valid.
RESULTS
Following exposure with yttrium trichloride hexahydrate, the mean cell viability was 86.7% compared to the negative control. This is above the threshold of 35%, therefore the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.
Any other information on results incl. tables
Optical Density (OD) and the calculated Non Specific Colour % (NSCliving%) of the additional control tissues
Additional control | OD Measured | OD Blank Corrected | NSC% (living) | |
Treated with | 1 | 0.054 | 0.007 | |
Test Item | 2 | 0.047 | 0.000 | 0.4 |
Mean | - | 0.003 |
Note: Mean blank value was 0.047. Optical density means the mean value of the duplicate wells for each sample (rounded to three decimal places).
Optical Density (OD) and the calculated relative viability % of the samples
Substance | OD Measured | OD Blank Corrected | Viability (%RV) | |
Negative Control | 1 | 0.940 | 0.893 | 97.4 |
(0.9% (w/v) NaCl) | 2 | 0.988 | 0.941 | 102.6 |
mean | - | 0.917 | 100.0 | |
Positive Control | 1 | 0.055 | 0.008 | 0.9 |
(Glacial Acetic Acid) | 2 | 0.050 | 0.003 | 0.3 |
mean | - | 0.005 | 0.6 | |
Test Item | 1 | 0.854 | 0.807 | 88.0 |
2 | 0.830 | 0.783 | 85.4 | |
mean | - | 0.795 | 86.7 |
Note: Mean blank value was 0.047. Optical density means the mean value of the duplicate wells for each sample (rounded to three decimal places).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure with the test item yttrium trichloride hexahydrate, the mean cell viability was 86.7% compared to the negative control. This is above the threshold of 35%, therefore the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.
In conclusion, in the in vitro EPISKIN™(SM) model test, the results indicated that the test item is non-corrosive to skin.
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