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EC number: 233-297-2 | CAS number: 10108-73-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-06 to 2012-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Cerium trinitrate
- EC Number:
- 233-297-2
- EC Name:
- Cerium trinitrate
- Cas Number:
- 10108-73-3
- Molecular formula:
- Ce.3HNO3
- IUPAC Name:
- cerium 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 UK Ltd., oxon, UK
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23 grams
- Housing: animals were housed individually in suspended solid-floor polypropylene cages furnished with softwood wood flakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 degrees Celsius
- Humidity (%): 30 to 70 percent
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours light and twelve hours darkness
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Preliminary Screening: 50% 25%. These concentrations were selected as maximum concentration suitable for dosing in solubility trials.
Main Test: 25%, 10%, 5%, 0% . These concentrations were selected as, at 50%, no excessive irritation was noted. - No. of animals per dose:
- Preliminary Screening: Two animals; one per dose level
Main Test: Four animals per tested concentration and in control group - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: the solubility of the test item in different vehicles was determined on the basis of maximising the concentration and solubility whilst producing a solution/suspension suitable for application. The vehicles tested were: acetone/olive oil (4:1) and dimethyl formamide. The concentration tested was 50% (0.5 g test iem + 0.5 g vehicle).
- Irritation: visually
- Lymph node proliferation response: expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: randomisation
- Criteria used to consider a positive response: if at least one concentration results in a 3-fold or greater in 3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
- Formulation: the test item was formulated within two hours of being applied. It was assumed that was stable for that duration. No analysis was performed to determine homogeneity, concentration or stability.
- Test item administration: daily application of 25 µL of the appropriate concentration to the dorsal surface of each ear for three consecutive days. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control resulted in a greater than threefold increase in 3HTdR incorporation (SI = 4.43).
Positive control DPM: 67578.50
Result: positive
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.62
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.95
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.12
- Test group / Remarks:
- 25%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 15 251.31
- Test group / Remarks:
- Vehicle
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 24 488.43
- Test group / Remarks:
- 5%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 29 705.23
- Test group / Remarks:
- 10%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 32 368.22
- Test group / Remarks:
- 25%
Any other information on results incl. tables
- Solubility: the vehicle suitable for dosing was dimethyl formamide.
- Clinical observations and mortality data: there were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
- Bodyweight: bodyweight changes of the test animals between day 1 and day 6 were comparable to those observed in the corresponding control group animals over the same period.
- Ear thickness: there were no increase in the ear thickness > 25% in any of the test or control animals on days 3 and 6.
- Skin irritation: no signs of irritation were seen in any of the animals throughout the test.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cerium trinitrate was considered to be a non-sensitiser under the conditions of the test.
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