Registration Dossier
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-17 - 2009-10-15
- 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 Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, Version 7.6, September 2009
- 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
- Species:
- other: Human Skin
- Strain:
- other: not applicable
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- other: wetted with DPBS-buffer
- Controls:
- other: positive control: Sodium dodecylsulphate, negative control: DPBS buffer
- Amount / concentration applied:
- Tissue Amount
1 25.9 mg
2 25.1 mg
3 24.7 mg - Duration of treatment / exposure:
- 60 minutes
- Observation period:
- ca. 57 hours
- Number of animals:
- 3 tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: % Formazan production
- Value:
- 113.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min.. Max. score: 50.0. Reversibility: no data. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is considered not irritant.
After the treatment, the relative absorbance values were increased to 113.2%: The value of the test item was higher than the value of the negative control.
The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 15.8 % (required: < 20%) thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.
For these reasons, the result of the test is considered valid. - Executive summary:
The test item is considered not irritant.
After the treatment, the relative absorbance values were increased to 113.2%: The value of the test item was higher than the value of the negative control.
The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 15.8 % (required: < 20%) thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.
For these reasons, the result of the test is considered valid.
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