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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
No skin irritation potential was observed. Furthermore, corrosive or a severe irritating potential to the eye were excluded by in-vitro testing.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin irritation potential of Silica-Zirkonia Filler was tested in-vitro according to OECD Guideline 431 and OECD Draft Proposal "In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method".
Skin corrosion ability was tested on a human three dimensional epidermal model (EpiDerm (EPI-200)), with 25 mg test material applied directly on top of the skin tissue. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test substance was not below 50% and 15%, respectively, the test material was not considered to be corrosive.
The skin irritation potential was tested on a human three dimensional epidermis model (EPISKIN-SM TM), with 10 mg test material applied directly on top of the skin tissue (0.38 cm2). A 15 min exposure to the test substance resulted in a 113% viability of treated skin tissue as compared to negative control treatment. Thus, the test material was considered to be non-irritant to human skin in vitro.
The eye corrosion or severe irritation potential of Silica-Zirkonia Filler was tested in-vitro according to OECD Guideline 437.
750 µL of a 20% suspension of the test material were introduced onto the epithelium of the cornea of a bovine eye and uniformously distributed over the entire cornea. The treated corneas showed opacity values ranging from 1 to 3 and permeability values ranging from 0 to 0.009, but were clear after the 240 minutes exposure. Hence, the in-vitro irritancy scores ranged from 1 to 3 after 240 minutes of treatment. According to the guideline the test substance can be regarded as neither corrosive nor severely irritating to the eye.
Justification for classification or non-classification
No classification for skin irritation is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively. Classification for eye irritation cannot be undertaken since only corrosion or a severe irritating potential were excluded.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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