Registration Dossier
Registration Dossier
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EC number: 234-465-8 | CAS number: 12005-21-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-10-21 to 2011-01-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pentaaluminium triyttrium dodecaoxide
- EC Number:
- 234-465-8
- EC Name:
- Pentaaluminium triyttrium dodecaoxide
- Cas Number:
- 12005-21-9
- Molecular formula:
- Al5O12Y3
- IUPAC Name:
- pentaaluminium triyttrium dodecaoxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): L181
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: VS 503G/10
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 18 - 19 weeks
- Weight at study initiation: 3.8 kg, 3.7 kg, 3.5 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- acclimatisation: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light):12 h light, 12 h dark
IN-LIFE DATES: From: 2010-12-16 To: 2010-12-26
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- No rinsing after application.
- Observation period (in vivo):
- 72 h after dosing
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No rinsing after application.
- Time after start of exposure: 72 h
SCORING SYSTEM: Grading of ocular lesion
Cornea: Degree of density (opacity, densest are taken for reading. Score 0 - 4
Iris: Score 0 - 4
Conjunctiva: Redness (refers to palpebral and bulbar conjunctiva; excluding cornea and iris. Score 0 - 4
Conjunctiva: Chemosis, swelling (refers to lids and/or nictitating membranes). Score 0 - 4
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: All 3 animals
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: All 3 animals.
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: All 3 animals.
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: All 3 animals.
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: All 3 animals.
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: All 3 animals.
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: All 3 animals.
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: All 3 animals.
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: All 3 animals.
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: All 3 animals.
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- other: All 3 animals.
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
Any other information on results incl. tables
Control negative in all animals 1 h, 24 h, 48 h and 72 h after application.
No clinical signs of toxicity were found in any of the 3 animals 1 h, 24 h , 48 h and 72 h after application of the test item.
The body weights of all 3 animals remained constant throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to the eye.
- Executive summary:
The eye irritating potential of L181 was examined in a GLP guideline study according to OECD 405.
Under the conditions of the present study, a single ocular application of the test item L181 to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 2 of the 3 animals and within 24 h in the third animal. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria of DSD (Directive 2001/59/EC) and the CLP-Regulation (EC) 1272/2008, the test item L181 does not have to be classified for eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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