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EC number: 233-153-9 | CAS number: 10045-95-1
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 3 December 2013 to 6 December 2013
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- relative humidity was out (min 23%) of target range (30-70%) during the study; this deviation is not considered to have impact on the outcome of the study and the interpretation of the results
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- relative humidity was out (min. 23%) of target range (30-70%) during the study; this deviation is not considered to have impact on the outcome of the study and the interpretation of the results
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- relative humidity was out (min. 23%) of target range (30-70%) during the study; this deviation is not considered to have impact on the outcome of the study and the interpretation of the results
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Neodymium trinitrate
- EC Number:
- 233-153-9
- EC Name:
- Neodymium trinitrate
- Cas Number:
- 10045-95-1
- Molecular formula:
- HNO3.1/3Nd
- IUPAC Name:
- neodymium trinitrate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft, 2173 Kartal, Csaszar ut 135, Hungary
- Age at study initiation: 16 weeks old
- Weight at study initiation: 3606-3825 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3 - 21.1 °C
- Humidity (%): 23 - 70%
- Air changes (per hr): 15 - 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily light, from 6.00 a.m. to 6.00 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The powdered test item was used in a single dose of 0.5 g applied to the test area. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal. The duration of the study was sufficient to evaluate the reversibility or irreversibility of the effects observed.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of intact skin, back and flanks of animals
- On the day of treatment, 0.5 g of the test item was placed on a surgical gauze pad (approximately 5 cm x 5 cm) and sufficient water was added to dampen the material to ensure good contact with the skin. This gauze pad was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was then wrapped with plastic wrap held in place with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The semi-occlusive dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.
SCORING SYSTEM: The dermal irritation scores were evaluated according to the scoring system by Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 4 hours exposure
- Basis:
- mean
- Remarks:
- (three animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- 4 hours exposure
- Basis:
- mean
- Remarks:
- (three animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- 4 hours exposure
- Basis:
- mean
- Remarks:
- (three animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- At observation 1, 24, 48 and 72 hours after patch removal, there were no observed irritancy signs noted on the skin of the treated animals. As no irritancy signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.
- Other effects:
- No mortality was observed during the study. There was no test item related effect on body weight. There were no test item related general clinical signs noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The irritant potential of neodymium trinitrate (hydrated form) to the skin was evaluated in three rabbits. The test item was considered not to be irritating.
Based on the results of this study, neodymium trinitrate does not require classification as skin irritant.
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