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EC number: 233-410-5 | CAS number: 10143-38-1
- 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 2017-08-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- acidity / alkalinity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 122 (Determination of pH, Acidity and Alkalinity)
- Principles of method if other than guideline:
- Electrochemic determination of pH: the pH-value of a 10% solution (or slurry) was determined electrochemically at 20°C with a calibrated pH meter (MA 235 Mettler Toledo). This value was recorded.
Determination of the acidic reserve: via titration. - GLP compliance:
- no
- Remarks:
- Company data performed according to an internal method that meets generally accepted scientific principles
- Specific details on test material used for the study:
- no details available
- Reagent:
- NaOH solution
- Details on titrant used:
- Determination of the alkaline or acid reserve via titration:
- For the determination of the alkaline reserve: the titration volume (in mL) of a 0.5 mol/L H2SO4 solution, which is required to achieve a pH of 10 of a 10% solution (or slurry) at 20°C, was recorded.
- For the determination of the acid reserve: the titration volume (in mL) of a 1 mol/L NaOH solution, which is required to achieve a pH of 4 of a 10% solution (or slurry) at 20°C, was recorded. - Key result
- pH value:
- 0.46
- Temp.:
- 20 °C
- Concentration:
- 10 vol%
- Key result
- Acidity or alkalinity:
- acidity
- Value:
- 10.03
- Remarks on result:
- other: Acid reserve
- Conclusions:
- The pH value of a 10% solution of dysprosium trinitrate was determined to be 0.46 and the acid reserve was 10.03. Based on these data, the outcome of the calculation for corrosivity was -0.37 (> -0.5). Therefore the substance was considered not to be corrosive.
pH | Acidic Reserve | Corrosive calculation | Corrosive? | |
Dysprosium nitrate | 0.46 | 10.03 | -0.37 | No |
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:
- Dysprosium trinitrate
- EC Number:
- 233-410-5
- EC Name:
- Dysprosium trinitrate
- Cas Number:
- 10143-38-1
- Molecular formula:
- Dy.3HNO3
- IUPAC Name:
- dysprosium trinitrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): dysprosium trinitrate (the hydrated form was used as test item)
- Physical state: crystalline solid
- Appearance: white or pale/slightly yellow crystal deliquescent
- Further details on test material confidential.
Constituent 1
- Specific details on test material used for the study:
- - The test material was used as supplied, although it was ground to a fine powder.
- Correction factor: No correction factor 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 EPISKINTM (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 (SM) (0.38 cm2), SkinEthic, France
- Tissue batch number(s):
- Batch No.: 16-EKIN-038, Expiry Date: 26 September 2016, used in Experiment I
- Batch No.: 16-EKIN-040, Expiry Date: 10 October 2016, used in Experiment II.
- Date of initiation of testing: Sep 21, 2016 (Experiment I); Oct 5, 2016 (Experiment II)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 23.2-25.9°C (Experiment I), 23.3-24.8°C (Experiment II)
- Temperature of post-treatment incubation (if applicable): 37.0 ± 1.0°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 15 min 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
NUMBER OF REPLICATE TISSUES 3:
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDI CTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-irritant to skin if the relative mean 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.
VALIDITY CRITERIA
The test is considered valid if:
- The absolute mean OD value of the three negative control tissues is between or equal to 0.6 and 1.5 and the standard deviation value (SD) of the % viability is ≤ 18.
- The mean percentage (relative) viability range for positive controls is ≤ 40% (relative to the negative control) and the standard deviation value (SD) of the % viability is ≤ 18.
- The SD calculated from individual % tissue viabilities of at least three identically treated replicates is < 18.
- The mean OD value of the blank samples (acidified isopropanol) is < 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
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 5 in Experiment I, 3 in Experiment II
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 3 replicates
- Value:
- 98.2
- 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: no (non specific colour % was calculated to be 0.9% but because this value is below 5% adidtional data calculation was not necessary)
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Optical Density and the calculated non-specific colour % of the additional control tissue (Experiment II)
Additional control | Optical Density (OD) |
NSC % | ||
measured | blank corrected | |||
treated with dysprosium trinitrate | 1 | 0.058 | 0.013 | |
2 | 0.047 | 0.002 | ||
mean | - | 0.007 | 0.9 |
Notes: mean blank value was 0.045. Optical density means the mean value of the duplicate wells for each sample (rounded to three decimal places).
Optical density and the calculated relative viability % of the samples (experiment I)
substance | optical density (OD) |
viability (% RV) | ||
measured | blank corrected | |||
negative control: phosphate buffered saline | 1 | 0.884 | 0.835 | 97.8 |
2 | 0.794 | 0.745 | 87.2 | |
3 | 1.031 | 0.982 | 115.0 | |
mean | - | 0.854 | 100.0 | |
positive control: 5% (w/v) SDS solution | 1 | 0.070 | 0.021 | 2.5 |
2 | 0.087 | 0.039 | 4.5 | |
3 | 0.087 | 0.038 | 4.5 | |
mean | - | 0.033 | 3.8 | |
test item: dysprosium trinitrate | 1 | 0.805 | 0.756 | 88.5 |
2 | 0.804 | 0.756 | 88.5 | |
3 | 1.005 | 0.957 | 112.0 | |
4 | 0.876 | 0.827 | 96.8 | |
5 | 0.947 | 0.899 | 105.2 | |
mean | - | 0.839 | 98.2 | |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure with dysprosium trinitrate, the mean cell viability was 98.2% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid. Based on these results, the test item is considered not classified according to the CLP Regulation.
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