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EC number: 240-514-4 | CAS number: 16469-17-3
- 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:
- weight of evidence
- Study period:
- 5 November 2009 - 11 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according 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:
- Dineodymium tricarbonate
- EC Number:
- 227-579-4
- EC Name:
- Dineodymium tricarbonate
- Cas Number:
- 5895-46-5
- Molecular formula:
- CH2O3.2/3Nd
- IUPAC Name:
- dineodymium tricarbonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Dineodymium tricarbonate
- Substance type: Monoconstituent
- Physical state and appearance: Extremely pale purple powder
- Analytical purity: 99.7% as Nd2O3/TREO; 59.8% TREO
- Purity test date: 22 January 2010
- Storage condition of test material: At room temperature in the dark, or at room temperature in the dark over silica
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, UK, Ltd, Oxon, UK
- Age at study initiation: nulliparous and non-pregnant
- Weight at study initiation: 15-23 g
- Housing: suspended solid floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): ad libitum, 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon UK
- Water (e.g. ad libitum): ad libitum, free of contaminants as analysed
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 deg C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- Range finding test: 25 µL of test material at 25% w/w in propylene glycol
Main test: 5, 10 and 25% w/w in propylene glycol - No. of animals per dose:
- 4 females per dose
- Details on study design:
- RANGE FINDING TEST
- Compound solubility: Compound was used as suspension in water.
- Irritation: Applied for 3 consecutive days and observed up to day 6. Any irritation was noted during this time.
- Lymph node proliferation response: NDA
MAIN STUDY
TREATMENTS
- 25%, 10% or 5% test material in propylene glycol was applied on the dorsal surface of the ear for 3 days in a row. [3H]-methyl thymidine was injected. All animals were observed daily, and weighed on day 1 and 6.
- Test material was formulated within 2 h of application. It was assumed that the formulation was stable. No analysis was conducted of the compound, this is a deviation with regard to GLP.
CRITERIA USED TO CONSIDER A POSITIVE RESPONSE
Proliferation response was expressed as the number of radioactive disintegrations per minute per lymph node and the ratio of [3H]TdR incoproration relative to that recorded for control nodes (called the stimulation index). Material is considered as sensitising if at least one concentration resulted in a 3-fold greater increase in radioactive incorporation compared to the control values. - Positive control substance(s):
- other: phenylacetaldehyde (90%)
Results and discussion
- Positive control results:
- 2.5% phenylacetaldehyde in propylene glycol resulted in a stimulation index of 4.2, i.e. it was considered to be a sensitiser.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 5% w/w
- Parameter:
- SI
- Value:
- 0.88
- Test group / Remarks:
- 10% w/w
- Parameter:
- SI
- Value:
- 0.93
- Test group / Remarks:
- 25% w/w
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 8 269.15
- Test group / Remarks:
- 5% w/w
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 6 613.97
- Test group / Remarks:
- 10% w/w
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 7 025.55
- Test group / Remarks:
- 25% w/w
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 7 529.69
- Test group / Remarks:
- vehicle
- Cellular proliferation data / Observations:
- No mortality or individual clinical observations
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following: OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002) and Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a maximum attainable concentration of 25% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a suspension in propylene glycol at concentrations of 25%, 10% or 5% w/w. A further group of four animals was treated with propylene glycol alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%w/w) in
propylene glycolStimulation Index
Result
5
1.10
Negative
10
0.88
Negative
25
0.93
Negative
The test material was considered to be a non-sensitiser under the conditions of the test.
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