Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-514-4 | CAS number: 16469-17-3
- 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:
- 12 January 2017 to 20 January 2017
- 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 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)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Neodymium trihydroxide
- EC Number:
- 240-514-4
- EC Name:
- Neodymium trihydroxide
- Cas Number:
- 16469-17-3
- Molecular formula:
- H3NdO3
- IUPAC Name:
- neodymium trihydroxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): neodymium trihydroxide
- Physical state: solid
- Appearance: clear blue powder (purple under UV light)
Constituent 1
- Specific details on test material used for the study:
- - correction factor: no correction factor is applied for this type of study
Test animals / tissue source
- Species:
- human
- Strain:
- other: Reconstructed human cornea-like epithelium (tissues)
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Source: MatTek, Bratislava, Slovak Republic
- Expiry date: The EpiOcularTM tissues were used within 72 hours of their production.
- Selection: At receipt, the tissues were inspected for obvious defects as they could have been rejected based on blistering, excess fluid or air bubbles below the tissue insert. Cultures with air bubbles under the insert covering greater than 50% of the insert area were not used.
- Storage conditions: At receipt, the living EpiOcularTM tissues were stored on their day of arrival.
- Description of the cell system used: EpiOcularTM living tissue consists of an airlifted, living, multilayered ocular tissue construction (surface 0.6 m2), reconstructed from normal (non-transformed) human-derived keratinocytes. This is a non-keratinized epithelium which models the corneal epithelium with progressively stratified, but not cornified cells. The cells are cultured in proprietary serum-free culture media, which induces corneal differentiation and the formation of the organotype 3D cornea-like model. The 3D tissue consists of highly organized cell layers similar to that found in the cornea. The model features a normal ultra-structure and is functionally equivalent to human in vivo tissue.
- Justification of the test method and considerations regarding applicability: The study was performed in a tier 2 strategy since the ocular corrosive or severe irritant potential of the test item could not be predicted in a tier 1 BCOP test (CiToxLAB France/Study No. 44478/TIB). The Epiocular Eye Irritation Test (EIT) protocol is particularly relevant for testing neat/non-diluted chemicals.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 51 mg
- Preparation: As the test item was a solid, the required quantity was weighed before treatment and was stored at room temperature and protected from humidity until application.
- Administration: The quantity of 51 mg +/- 1 mg was applied evenly to the surface of each tissue, taking care to spread it over the whole tissue surface area without damaging the tissue sample. - Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Details of the test procedure used:
- RhCE tissue construct used, including batch number: EpiOcular tissue, MatTek, Bratislava, Slovak Republic
- Doses of test chemical and control substances used: 51 mg of test item, 50 µL of deinonized water for negative control, 50 µL methyl acetate for positive control.
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable): 6 hours at 37°C, soaked in assay medium 25 minutes at room temperature, blotted, and then incubated for 18 hours at 37°C, 5% CO2.
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable): yes. No coloring potential found; no additional controls needed.
- Number of tissue replicates used per test chemical and controls (positive control, negative control): 2 - Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device: 570 nm plate reader
- Description of the method used to quantify MTT formazan: Following incubation, tissues were transferred to new well plates with 0.3 mL freshly prepared MTT solution and incubated for 3 hours at 37°C, 5% CO2.
- Acceptable variability between tissue replicates for positive and negative controls: Negative control acceptance criteria - Mean cOD between 0.8 and 2.5. Positive control - Relative mean viability of the positive control is < 50% of the relative mean viability of the negative control.
- Acceptable variability between tissue replicates for the test chemical: Acceptable if the difference of viability between the two tissue replicates is < 20%.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Optical density measurement
- Run / experiment:
- Mean of two replicates
- Value:
- 1.604
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Relative viability in %
- Run / experiment:
- Mean of duplicate tissues
- Value:
- 103
- 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:
- - All test item-treated tissues appeared blue (with a white spot for one of the treated tissues) which was considered indicative for viable tissues.
- All of acceptance criteria for the negative and positive controls were fulfilled, therefore the study was considered to be valid.
- As the mean viability was > 60% after the MTT reduction, the results met the criteria for a non-irritant response.
OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not specified
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: Not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test item is considered to be non-irritant to Reconstructed human Cornea-like Epithelium.
According to the results of this study, the classification of the test item should be: No Category (GHS 2015 and Regulation (EC) No. 1272/2008).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.