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EC number: 266-047-6 | CAS number: 65997-18-4 Frit is a mixture of inorganic chemical substances produced by rapidly quenching a molten, complex combination of materials, confining the chemical substances thus manufactured as nonmigratory components of glassy solid flakes or granules. This category includes all of the chemical substances specified below when they are intentionally manufactured in the production of frit. The primary members of this category are oxides of some or all of the elements listed below. Fluorides of these elements may also be included in combination with these primary substances.@Aluminum@Manganese@Antimony@Molybdenum@Arsenic@Neodymium@Barium@Nickel@Bismuth@Niobium@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Cerium@Silver@Chromium@Sodium@Cobalt@Strontium@Copper@Tin@Gold@Titanium@Iron@Tungsten@Lanthanum@Vanadium@Lead@Zinc@Lithium@Zirconium@Magnesium
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guideline for testing of chemicals, No. 407.
- Deviations:
- yes
- Remarks:
- modified for intravenous application.
- Principles of method if other than guideline:
- Repeated dose intravenous toxicity.
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Details on test material:
- IPS Empress 2, group 1 frits. Group 1 frits are double-fired zirconium white, without Zn, Pb or Ba.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEK 7012 rodent diet (Harlan) and tap water available ad lib. Age at study initiation >34 days. Weight range 20.3-22.9g. Temperature 20 +- 5˚C, 30-70% relative humidity, 12 h dark/12 h light cycle.
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- other: 0.9% NaCl solution
- Details on exposure:
- Two weeks of daily (5 days/week) intravenous injections of test extract.
- Duration of treatment / exposure:
- Two weeks.
- Frequency of treatment:
- Daily (5 days/week)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25 ml/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Only limit test with prepared extract.
Examinations
- Observations and examinations performed and frequency:
- Clinicals signs were observed daily. Body weights were measured on days 0, 7 and 14. Haematology, prior to necropsy.
- Sacrifice and pathology:
- Necropsy day 14. Gross necropsy: examination of external body surfaces, all orifices, cranial/thoracic and abdominal cavities and their contents. Organs were preserved and liver, kidneys/adrenals (combined) and gonad weights were determined.
- Other examinations:
- Not applicable
- Statistics:
- Not applicable
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- At necropsy, histopathology revealed slight subacute hepatitis, slight fatty infiltration in the heart and slight nephropathy in animals from all groups (including controls); this was not considered relevant by the study author.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 25 other: NaCl extract of test frit/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: greater than or equal to 25 ml NaCl extract of test frit/kg bw/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for IPS Empress 2 frit (Group 1 ceramic frits) in mice is greater than or equal to 25 ml NaCl extract of test frit/kg bw/day.
- Executive summary:
The NOAEL for IPS Empress 2 frit (group 1(exempt) ceramic frit) in mice is greater than or equal to 25 ml NaCl extract of test frit/kg bw/day. This study (Krenzer, 2004) is considered reliable (2). It is a GLP compliant, guideline study with minor restrictions in design and/or reporting, but it is otherwise adequate for assessment.
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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