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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restricitons.
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Optimet TM RG
- IUPAC Name:
- Optimet TM RG
- Details on test material:
- - Name of test material (as cited in study report): Optimet TM RG
- Analytical purity: not reported
- Lot/batch No.: Batch No.10GUS013
- Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Not reported
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent surfaces of untreated skin served as a control for the trial.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- Semi-occlusive dressings held the test item in place for 3 minutes, 1 hour and 4 hours on the skin of the first animal and for 4 hours for the two other animals.
- Observation period:
- Any cutaneous lesion was evaluated approximately one hour, 24, 48 and 72 hours after removal of the dressing.
- Number of animals:
- 3
- Details on study design:
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No cutaneous lesion was observed.
Any other information on results incl. tables
Under the experimental conditions adopted, Optimet TM RG (Batch No.10GUS013) was found to be not irritating for the skin of the rabbit.
Classification according to DSD (Directive No.67/548/EEC) and subsequent amendments and CLP (Regulation No.1272/2008) is not required.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: DSD and CLP
- Executive summary:
Bouchard, A. (2010)
In a primary dermal irritation study, the skin irritation/corrosion potential of Optimet TM RG (Batch No.10GUS013) was tested. 0.5 g of the test substance was applied on the skin of 3 rabbits under semi-occlusive conditions for 3 minutes, 1 hour and 4 hours on the skin of the first animal and for 4 hours for the two other animals.
The application of the test item did not induce colouring of the application site and did not interfere with grading of any skin lesion.
Any cutaneous lesion was evaluated approximately one hour, 24, 48, and 72 hours.
No other cutaneous lesion was observed.
Under the experimental conditions adopted, the test item was found to be a non skin irritant.
On the basis of the results of the present study, classification according to Directive No. 67/548/EEC and subsequent amendments and CLP regulation No. 1272/2008 is not required.
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