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EC number: 238-510-2 | CAS number: 14507-19-8
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 February 2013 - 21 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lanthanum trihydroxide
- EC Number:
- 238-510-2
- EC Name:
- Lanthanum trihydroxide
- Cas Number:
- 14507-19-8
- Molecular formula:
- H3LaO3
- IUPAC Name:
- lanthanum trihydroxide
- Test material form:
- other: solid (unspecified)
- Details on test material:
- - Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: New Zealand White
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.42 or 2.44 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): Free access to mains drinking water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least 15 per hour.
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continuous light (0600 to 1800) and twelve hours darkness.
IN-LIFE DATES: From: 11 February 2013 To: 21 February 2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated and was used for control purposes.
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2. Initially, one animal was treated; after consideration of the ocular response, a second animal was treated.
- Details on study design:
- Immediately after administration of the test material, an assessment of the initial pain reaction was made.
SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize numerical evaluation.
Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period. Any clinical signs of toxicity, if present, were also recorded.
Draize Scale for Scoring Ocular Irritation
1. CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris):
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis:
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids half closed to completely closed 4
Discharge:
No discharge 0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs a considerable area around the eye 3
2. IRIS
Values:
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
3. CORNEA
Degree of Opacity (most dense area used):
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris not discernible through the opacity 4
Area of Cornea Involved:
One quarter (or less) but not zero 1
Greater than one quarter but less than half 2
Greater than half but less than three quarters 3
Greater than three quarters, up to whole area 4
TOOL USED TO ASSESS SCORE: Any additional ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: discharge score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Individual scores are given in Table 2.
No corneal effects were noted during the study. Iridial inflammation (Grade 1) was noted in both treated eyes one hour after treatment.
Moderate conjunctival irritation (Grade 2 redness, Grade 2 chemosis and Grade 2 discharge) was noted in both treated eyes one hour after treatment. Minimal conjunctival irritation (Grade 1 redness and Grade 1 chemosis) was noted in both treated eyes at the 24 hour observation. Minimal conjunctival irritation (Grade 1 redness in both treated eyes and Grade 1 chemosis in one treated eye) was noted in both treated eyes at the 48 hour observation.
Both treated eyes appeared normal at the 72 hour observation and the study was therefore terminated. - Other effects:
- BODYWEIGHT
Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 2: Individual Scores for Ocular Irritation
Rabbit Number and Sex |
72956 Male |
72987 Male |
||||||
IPR = 2 |
IPR = 2 |
|||||||
Time After Treatment |
1 hour |
24 hours |
48 hours |
72 hours |
1 hour |
24 hours |
48 hours |
72 hours |
Cornea Degree Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Redness |
2 |
1 |
1 |
0 |
2 |
1 |
1 |
0 |
Chemosis |
2 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
Discharge |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
IPR = Initial pain reaction; a score of 2 indicates slight initial pain. The rabbit blinks and tries to open the eye but reflex closes it.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the test material requires no classification in accordance with EU criteria.
- Executive summary:
The irritancy potential of the test material was assessed in vivo in accordance with the standardised guidelines OECD 405 and EU Method B.5.
A single application of 100 mg of the test material was sequentially administered to the right eye of two New Zealand White rabbits. The treated eyes were not irrigated; the left eye remained untreated and served as the control. The animals were observed for ocular effects 1, 24, 48 and 72 hours after administration of the test material.
The individual mean scores for corneal opacity and iritis were 0.0 for both animals. The individual mean scores for conjunctival redness were 0.7 for both animals. The individual mean scores for chemosis were 0.3 and 0.7. Both treated eyes appeared normal at the 72 hour observation and the study was therefore terminated.
Under the conditions of this study, the test material requires no classification in accordance with EU criteria.
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