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Registration Dossier
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EC number: 266-340-9 | CAS number: 66402-68-4 This category encompasses the various chemical substances manufactured in the production of ceramics. For purposes of this category, a ceramic is defined as a crystalline or partially crystalline, inorganic, non-metallic, usually opaque substance consisting principally of combinations of inorganic oxides of aluminum, calcium, chromium, iron, magnesium, silicon, titanium, or zirconium which conventionally is formed first by fusion or sintering at very high temperatures, then by cooling, generally resulting in a rigid, brittle monophase or multiphase structure. (Those ceramics which are produced by heating inorganic glass, thereby changing its physical structure from amorphous to crystalline but not its chemical identity are not included in this definition.) This category consists of chemical substances other than by-products or impurities which are formed during the production of various ceramics and concurrently incorporated into a ceramic mixture. Its composition may contain any one or a combination of these substances. Trace amounts of oxides and other substances may be present. The following representative elements are principally present as oxides but may also be present as borides, carbides, chlorides, fluorides, nitrides, silicides, or sulfides in multiple oxidation states, or in more complex compounds.@Aluminum@Lithium@Barium@Magnesium@Beryllium@Manganese@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Carbon@Sodium@Cerium@Thorium@Cesium@Tin@Chromium@Titanium@Cobalt@Uranium@Copper@Yttrium@Hafnium@Zinc@Iron@Zirconium
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-12 - 2009-08-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 405, dated 24. April 2002 and ICCVAM recommended test method protocol dated November 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ceramic materials and wares, chemicals
- EC Number:
- 266-340-9
- EC Name:
- Ceramic materials and wares, chemicals
- Cas Number:
- 66402-68-4
- Molecular formula:
- spinel of the pleonaste type containing (Mg,Fe)(Al,Fe)2O4
- IUPAC Name:
- not applicable
Constituent 1
Test animals / tissue source
- Species:
- other: chicken's eggs
- Strain:
- other: Leghorn
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- mean 291.7 mg
- Duration of treatment / exposure:
- 300 seconds
- Observation period (in vivo):
- 300 seconds
- Number of animals or in vitro replicates:
- 6 chicken's eggs
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Mean Irritation Score
- Basis:
- mean
- Time point:
- other: 301 seconds
- Score:
- 0
- Max. score:
- 21
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This in vitro study was performed to assess the irritating potential of pleonastic spinel by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution) and sodium hydroxide (0.1-N solution) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The negative control showed no irritation.
The value for sodium hydroxide solution was slightly out of the range of the historical data, this was considered as uncritical, because the positive control showed severe irritation and the deviation was only marginal (0.03 points outside the range of the historical data).
The test item was tested pure. A mean irritation score of 0.0 was calculated, corresponding to a classification as "not irritant".
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid. - Executive summary:
This in vitro study was performed to assess the irritating potential of pleonastic spinel by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution) and sodium hydroxide (0.1-N solution) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The negative control showed no irritation.
The value for sodium hydroxide solution was slightly out of the range of the historical data, this was considered as uncritical, because the positive control showed severe irritation and the deviation was only marginal (0.03 points outside the range of the historical data).
The test item was tested pure. A mean irritation score of 0.0 was calculated, corresponding to a classification as "not irritant".
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
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