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EC number: 233-238-0 | CAS number: 10099-59-9
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 October 2012-28 November 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study performed according to OECD Guideline 429 and EU Method B42. The study has been scored Klimisch 2 to reflect the ambiguity of the results (expert judgment).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Lanthanum trinitrate
- EC Number:
- 233-238-0
- EC Name:
- Lanthanum trinitrate
- Cas Number:
- 10099-59-9
- Molecular formula:
- H3LaN3O9+3
- IUPAC Name:
- lanthanum trinitrate
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Individually housed in suspended solid-floor polypropylene cages with softwood flakes
- Diet (e.g. ad libitum): ad libitum 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Range-finding test:
10%, 25%, 50%
Main test:
2.5, 5, 10% - No. of animals per dose:
- Range-finding test: 1
Main test: 4 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: soluble in vehicle
- Irritation: excessive ear thickness > 25%
- Lymph node proliferation response: Ratio of 3HTdR incorportation relative to control.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Threefold or greater increase in 3HTdR incorporation relative to control.
TREATMENT PREPARATION AND ADMINISTRATION:
- 25 µL test item to dorsal ear surface days 1, 2, and 3
- Day 6; injection via tail vein of 250 µL PBS containing 3H-methyl thymidine (80 µCi/mL, specific activity 2.0 Ci/mmol), total 20µCi per mouse.
- Asphyxiation by carbon dioxide 5 hours after 3HTdR injection.
- Auricular lymph nodes excised, drained and pooled for each group, and 1 mL PBS added to pool.
- Cells disaggregated through 200 mesh stainless gauze, rinsed w/4mL of PBS into a petri dish.
- Suspension was transferred to a centrifuge tube w/rinse, pelleted and re-suspended twice in PBS.
- Pellet resuspended in 3 mL 5% TCA.
- After 18 hours at 4°C; precipitates recovered by centrifugation and re-suspended in 1 mL TCA and transferred to scintillation vial.
- Disintegrations per minute counted with Beckman LS6500 system
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Disintegrations per minute: 72230.33 dpm
Stimulation Index: 11.57
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Vehicle-na Test item: 2.5%-2.23 5%-3.15 10%-3.26
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle-6242.04 dpm Test item: 2.5%-13890.88 dpm 5%-19675.01 dpm 10%- 20356.72 dpm
Any other information on results incl. tables
Range finding test: excessive ear thickness (>25%) at 50% and 25% w/w in vehicle up to day 6 after exposure (~42 % ear thickness increase at both 50 and 25 %).
Main study - Observations
- Clinical Observations: there were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
- Body weights: bodyweight changes of test animals were comparable to corresponding control (vehicle) animals.
- Ear thickness: there was no increase in ear thickness (>25%) in any of the test or control animals on days 3 and 6.
Main study
- Calculation of EC3 value: 4.59%
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- At concentrations of 5% and 10% w/w in dimethyl formamide the stimulation indices are only slightly higher than the threefold increase in 3HTdR incorporation compared to the control values (3.15 and 3.26 respectively). It was also observed that the preliminary screening animals showed excessive or elevated increases in ear thickness changes, indicating irritation potential. On this basis the test item can not be clearly classified as a sensitiser.
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