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
Endpoint summary
Administrative data
Description of key information
"Reaction product of thermal process between 1000°C and 2000°C of mainly aluminium oxide and calcium oxide based raw materials with at least CaO+Al2O3+MgO >80% , in which aluminium oxide, magnesium oxide and calcium oxide in varying amounts are combined in various proportions into a multiphase crystalline matrix" was found to be irritant to the eyes but not irritant to the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
In primary dermal irritation studies, the skin irritation/corrosion potential of OptimetTM RG (Bouchard, A., 2010), OptimetTMAL (Bouchard, A., 2010), and OptimetTM SI (Gribaudo, S., 2010) was tested.
In each study 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 cutaneous lesion was observed at 24, 48, and 72 hours after application. Under the experimental conditions adopted, the test items were found to be non skin irritants.
Eye irritation:
The primary eye irritation study of OptimetTM RG was investigated in a study comparable to OECD 405 (Bouchard, 2010). The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion but a trace of test item was seen for two animals one hour after introduction into the conjunctival sac and in order to allow satisfactory conditions for grading, the treated eye was gently rinsed using 10 mL of sterile isotonic saline solution. The controlateral eye was similary rinsed and used for control purposes.
One hour after instillation, all animals had severe chemosis (score 2 to 4) with lacrimation (score 2) and redness of the conjunctivae (score 1 to 2).
24, 48 and 72 hours after instillation, chemosis (score 3 to 4) and redness of the conjunctivae (score 2 to 3) persisted in three animals. Lacrimation (score 1 to 2) persisted in two animals 24 hours after, in one animal 48 hours after and recurred in two animals 72 hours after. The fourth animal had a slight chemosis (score 1) and a slight redness of the conjunctivae (score 1) 24 hours after instillation and no ocular lesion persisted at time 48, 72 hours and 8 days after instillation. Iris lesions (score 1) were observed 24 and 48 hours after instillation for one animal. On D8 and D15, only one out of three observed animals presented chemosis (score 1 to 2) and redness of the conjunctivae (score 1). No ocular lesion persisted 22 days after instillation.
In another irritation study, the eye irritation potential of OptimetTM AL was tested comparable to OECD 405 (Bouchard, 2010). The application of the test item did not induce colouration of the application site and did not interfere with grading of any eye lesion.
One hour after instillation, two animals had a chemosis (score 1 and 3) and all animals had lacrimation (score 1 to 2) and slight to moderate redness of the conjunctivae (score 1 to 2).
A slight lacrimation (score 1) persisted in one animal 24 and 48 hours after instillation and as light redness of the conjunctivae (score 1) persisted in all animals 24 hours after the instillation and in one animal 48 hours after instillation.
No ocular lesion persisted at the end of the study (i.e. 72 hours after instillation).
The eye irritation potential of OptimetTM SI was also investigated in a study comparable to OECD 405 (Gribaudo, 2010). The application of the test item did not induce colouration of the application site and did not interfere with grading of any eye lesion. No ocular lesion persisted 24, 48 and 72 hours after instillation of OptimetTM SI.
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin irritation:
Optimet was found to be a non skin irritant.
On the basis of the results of the present study, classification according to DSD Directive No. 67/548/EEC and subsequent amendments and CLP regulation No. 1272/2008 is not required.
Eye irritation:
Optimet was found to be irritanting to the eye of the rabbit.
Classification according to Directive No.67/548/EC and subsequent amendments and CLP Regulation No.1272/2008:
Symbol: Xi.
Indication of danger: IRRITANT – Category 2.
Risk phrase: R36: irritating to eyes.
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