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 >80% , in which aluminium oxide and calcium oxide in varying amounts are combined in various proportions into a multiphase crystalline matrix" was found to be corrosive to the eyes but non 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)
Additional information
Skin irritation:
In primary dermal irritation studies, the skin irritation/corrosion potential of LDSF®RG (Bouchard, A., 2010), and LDSF®LT (Bouchard, A., 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 potential of LDSF®LT was investigated in a study comparable to OECD 405 (Bouchard, 2010). Only one animal was used for the study because LSDF®LT caused local pain and was probably severely irritating or corrosive. Therefore, exposure of two additional animals was not done.
The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion.
One hour after instillation, the animal had a severe chemosis (score 4) with lacrimation (score 2) and a severe redness of the conjunctivae (score 3). Chemosis (score 3 to 4) and redness of conjunctivae (score 2 to 3) persisted up to D 16. Iris lesions were observed 24 hours after instillation and on D 8. On D 15, corneal lesions (score 2) involved an area of a quarter or less of the total area were observed. On D 16, greater than three-quarters, up to whole area was observed. Pus in the conjunctival sac was also observed 24 hours after instillation.
Because of the intensity of the lesions and according to the qualified veterinarian diagnosis, the study was stopped on D16.
Because ocular lesions and animal pain increased during the reversibility period and under the experimental conditions adopted, LSDF®LT should be classified as Irritant-Category 1 for the eye of the rabbit.
In another irritation study, the eye irritation potential of LDSF®RG was tested 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. Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours, 72 hours for two animals and 8 days, 15 days and 22 days for the first animal after instillation of LDSF®RG.
Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours. Results obtained were as follows:
One hour after instillation, all animals had chemosis (score 1 to 2) with lacrimation (score 2) and slight redness of the conjunctivae (score 1). Chemosis (score 1 to 2) and slight redness of the conjunctivae (score 1) persisted in two animals 24 and 48 hours after the instillation and in one animal 72 hours after instillation. Lacrimation (score 2) was observed in thefirst animal 48 hours after instillation and persisted 72 hours after. This animal had also chemosis (score 1 to 2) on D 8 and D 15 and lacrimation (score 2) on D 15.
No ocular lesion persisted in any animal at the end of the exposure period (i.e.on D 22 for thefirst animal and at time 72 hours for the two other animals).
Effects on eye irritation: corrosive
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Skin irritation:
LDSF 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:
LDSF fulfils the DSD and CLP criteria for classification as severe eye irritant.
DSD: Xi, R41: Risk of serious damage to eyes.
CLP: Eye Irritant - Category 1
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