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EC number: 931-210-9 | CAS number: 1266534-73-9
- 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:
- 11 Aug - 25 Aug 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministreium für Umwelt, Landwirtschaft und Verbraucherschutz, Mainzer Str. 80, 65189 Wiesbaden, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- silicon(4+) dialuminium(3+) antimony nickel vanadium pentaoxidandiide
- EC Number:
- 931-210-9
- Cas Number:
- 1266534-73-9
- Molecular formula:
- (M2/nO*Al2O3*ySiO2*wH2O)x*(Ti,Sb,Ni,V O2)z*(Al2O3)k*(Al2Si2O7)l n is the valency of the cation M, predominantly Na, and for Na is n=1; y can range from 2 to 222; w can range from 0 to 30; x can range from 0.2 to 0.7; z can range from 0.01 to 0.05; k can range from 0.03 to 0.39; l can range from 0.26 to 0.39
- IUPAC Name:
- silicon(4+) dialuminium(3+) antimony nickel vanadium pentaoxidandiide
- Details on test material:
- - Name of test material (as cited in study report): LOOP
- Chemical name: Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony
- Analytical purity: 99%
- Impurities (identity and concentrations):
- Lot/batch No.: 09303322/1
- Expiration date of the lot/batch: 29 Jun 2011
- Storage condition of test material: room temperature
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 B.V., Postbus 6174, 5960 AD Horst, The Netherlands
- Strain: CBA/CaOlaHsd
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.4 - 22.5 g
- Housing: single caging
- Diet (ad libitum): pelleted standard diet
- Water (ad libitum): tap water
- Acclimation period: at least 5 days prior to the start of the dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45 - 80 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- Purity: 99%
- Concentration:
- 5, 10 and 25% (w/w) suspension in propylene glycol
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- two animals, topical application with ???% each on three consecutive days
- Compound solubility: 25% (w/w) was the highest test item concentration, which could be achieved after grinding in a mortar
- Irritation: no signs of irritation or systemic toxicity (recorded within 1h and 24 h and 7 d after application)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: First: at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index. Second: compatibel with a conventional dose-response.
TREATMENT PREPARATION AND ADMINISTRATION:
- Dilutions were prepared individually, homogeneity was maintained using a magnetic stirrer
- Topical application: Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with the different test item concentrations. The application volume (25 µl) was spread over the entire dorsal surface (diameter 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
- Administration of 3H-Methyl Thymidine (³HTdR): Five days after the first topical application, all mice were administered with 250 µl of 78.5 µCi/mL 3HTdR (corresponds to 19.6 µCi ³HTdR per mouse) by intravenous injection via a tail vein.
- Determination of Incorporated ³HTdR: Approximately five hours after treatment with ³HTdR all mice were euthanised. The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). The pooled lymph nodes were prepared according to the guideline. The level of ³HTdR incorporation was then measured on a beta-scintillation counter.
OBSERVATIONS
- Mortality/viability: once daily
- Body weights: prior to the first application and prior to the treatment with ³HTdR
- Clinical signs: within 1 h of each application and 24 ± 4 h after the first and second appplication as well as on the day of preparation. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Body weight: mean values and standard deviations were calculated.
[³H]TdR incorporation was calculated as mean cpm ± SD, and stimulation indices of lymph node cell proliferation between substance-treated and vehicle-treated groups were calculated.
Results and discussion
- Positive control results:
- DPM per lymph node:
0 (vehicle group, acetone:olive oil (4:1)): 727.6
5 % test item: 1303.6
10 % test item: 1518.4
25 % test item: 4976.6
Stimulation index:
5 % test item: S.I. = 1.79
10 % test item: S.I. = 2.09
25 % test item: S.I. = 6.84
The positive control substance showed the expected positive result (S.I. > 3).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: vehicle control: - 5% (w/w): 1.11 10% (w/w): 1.17 25% (w/w): 0.98
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per lymph node: vehicle control: 185.0 5% (w/w): 204.6 10% (w/w): 216.5 25% (w/w): 178.5
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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