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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 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : lack of details on test substance
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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
- Physical state: solid
- Analytical purity: not reported
- Lot/batch No.: 10GUS013
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Until the observation period of 22 days (Exception: 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 rinsed)
- Observation period (in vivo):
- Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours, 72 hours and 8 days after instillation for two animals and 15 days and 22 days after instillation of Optimet TM RG for one animal.
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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 10mL of sterile isotonic saline solution. The controlateral eye was similary rinsed and used for control purposes.
SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: due to a technician error, the animal was euthanased before the observation on day 8
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 22 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- other: due to a technician error, the animal was euthanased before the observation on day 8
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- 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 of three observed animals had chemosis (score 1 to 2) and redness of the conjunctivae (score 1). No ocular lesion persisted 22 days after instillation.
Any other information on results incl. tables
Table 1: Mean Index:
Treatment |
Animal number |
Chemosis |
Redness |
Iris |
Cornea |
OptimetTMRG OptimetTMRG OptimetTMRG OptimetTMRG |
1 2 3 4 |
4 0.33 3.33 1.67 |
2.67 0.33 2 1.33 |
0.67 0 0 0 |
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information DSD: Xi, R36: irritating to eyes; CLP: Eye Irritant - Category 2 Criteria used for interpretation of results: other: DSD and CLP
- Executive summary:
Bouchard, A. (2010)
In a primary irritation study, the eye irritation potential of OptimetTM RG (Batch No.10GUS013) was tested. 0.1 g of the test substance was introduced into the conjunctival sac of the left eye of each of the four animals. The untreated right eye served as a control.
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.
Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours, 72 hours and 8 days after instillation for two animals and 15 days and 22 days after instillation of OptimetTM RG for one animal.
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 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 of three observed animals had chemosis (score 1 to 2) and redness of the conjunctivae (score 1). No ocular lesion persisted 22 days after instillation.
Under the experimental conditions adopted, OptimetTM RG was found to be irritant for 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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