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EC number: 215-234-0 | CAS number: 1314-37-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 March 2014 - 10 December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ytterbium (III) oxide
- EC Number:
- 215-234-0
- EC Name:
- Ytterbium (III) oxide
- Cas Number:
- 1314-37-0
- Molecular formula:
- O3Yb2
- IUPAC Name:
- ytterbium(III) oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name (as on the report): Ytterbium(III) oxide
CAS no.: 1314-37-0
Batch no.: 11NYL17
Purity: 99.9%
Date of expiry: 9 December 2018
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: On the day of administration, the test item was freshly formulated at a concentration of 200 mg/mL (anhydrous form) with the vehicle.
- No correction factor was used in this study.
FORM AS APPLIED IN THE TEST (if different from that of starting material): formulation with a 0.5% aqueous solution of carboxymethylcellullose at a concentration of 200 mg/mL
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks old
- Weight at study initiation: 236.10 g (average) at the start of the study (Day 1) (SD = 14.628)
- Fasting period before study: Yes. Food was removed from the cages overnight prior to dosing (Day -1) and was made available approximately 4 h after dosing.
- Housing: Up to 5 animals per cage. Polisulphone solid bottomed cages of 59.5x38x20 cm with nesting material provided into suitable bedding bags.
- Diet (e.g. ad libitum): Ad libitum (except for the dosing procedure). 4 RF 18 (Mucedola S.r.l., Via G. Galilei 4, 20019, Settimo Milanese (MI), Italy.
- Water (e.g. ad libitum): Ad libitum. Drinking water supplied to each cage via a water bottle.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): ca. 15-20
- Photoperiod (hrs dark / hrs light): 12 L:12 D - artificial (fluorescent tubes)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: not reported - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 1 during preliminary test, 4 during main test
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
*Mortality and morbidity: twice daily
*Clinical signs: on dosing, approximately 0.5 h after dosing, approximately 2 h after dosing, approximately 4 h after dosing, and daily thereafter for a total of 14 days
*Body weight: at allocation (Day -1), on the day of dosing (Day 1), and on Days 2, 8 and 15
- Necropsy of survivors performed: Yes, on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the gastro-intestinal tract). Animals were sacrificed by carbon dioxide narcosis.
Results and discussion
- Preliminary study:
- During the observation period, no mortality occurred and no clinical signs were noted in the single female animal dosed at 2000 mg/kg. Therefore, the dose for the main study was also 2000 mg/kg.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed in the 4 animals treated at 2000 mg/kg.
- Clinical signs:
- other: No clinical signs were observed in the 4 animals treated at 2000 mg/kg.
- Gross pathology:
- No abnormalities were observed at the necropsy examinations.
- Other findings:
- No other findings reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the acute oral LD50 value of ytterbium oxide was found to be above 2000 mg/kg bw in female Sprague Dawley rats. No mortality and no clinical signs were observed in the treated animals. According to these results, ytterbium oxide needs not to be classified according to CLP criteria.
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