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EC number: 910-388-1 | CAS number: -
- 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:
- 26 Apr 2010 - 10 May 2010
- 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
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of silicon dioxide and zirconium dioxide
- EC Number:
- 910-388-1
- Molecular formula:
- not applicable (multi-constituent substance)
- IUPAC Name:
- Reaction mass of silicon dioxide and zirconium dioxide
- Details on test material:
- - Name of test material (as cited in study report): Silica-Zirkonia Filler
- Physical state: White powder
- Batch: IT-253
- Analytical purity of components: 72.4% silicon dioxide (CAS No. 7631-86-9) and 26.0% zirconium dioxide (CAS No. 1314-23-4) and a not stated percentage of disodium oxide (CAS No. 1313-59-3)
- Storage: at room temperature in the dark
- Stability: stable under storage conditions
- Expiry date: 20 Nov 2010
- not soluble in vehicle propylene glycol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: 8-14 weeks
- Weight at study initiation: 20-24 g
- Housing: Individual in Macrolon cages on sterilized sawdust bedding
- Diet (ad libitum): pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-3
- Humidity (%): 40-84
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Remarks:
- (Merck, Germany)
- Concentration:
- 0, 10, 25 and 50% (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The compound was not soluble in the vehicle.
- Irritation: In the preliminary irritation study two substance concentrations were tested (25 and 50% w/w). The highest concentration was the maximum concentration as required in the test guideline (50% for solids). Two young adult animals were treated with one concentration on three consecutive days. Approx. 3-4 hours after the last exposure, the irritation of the ears was assessed. Bodyweights were determined on days 3.
- Lymph node proliferation response: not measured in the pretesting. Ear thickness was not determined.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: SI ≥3
TREATMENT PREPARATION AND ADMINISTRATION:
On 3 consecutive days, test substances were applied on the ears (25 µL/ear) in a open application manner. Negative control animals were treated similarly, but with the vehicle alone. 3 days after the last exposure, all animals were injected with 3H-methyl thymidine and after 5 hours the draining (auricular) lymph nodes were excised and the relative size of the nodes (as compared to normal) was estimated by visual examination. The lymph nodes were pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The 6-month reliability check with Alpha-hexylcinnamicaldehyde indicated that the LLNA as performed at this laboratory was appropriate for testing contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values at 10, 25 and 50% were 1.6, 1.4 and 1.3, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values at 0, 10, 25 and 50% were 285, 466, 391 and 383 DPM.
Any other information on results incl. tables
No irritation of the ears was observed in any of the treated animals. Animals treated at 50% showed white test substance remnants on the ears, but the remnants did not hamper scoring for skin irritation. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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