Registration Dossier
Registration Dossier
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EC number: 234-465-8 | CAS number: 12005-21-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-12-13 to 2011-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- 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 %
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 24 weeks
- Weight at study initiation: 4.4 kg, 4.3 kg, 4.8 kg
- Housing: Semi barrier in an air-conditioned room, housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2010-12-08 To:2010-12-20
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: The untreated right body sight served as control. In order to confirm the negative response, two additional animals were treated with a patch without the test item.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): enough for moistening the test item
- Purity: ca. 100 % - Duration of treatment / exposure:
- Initial test: 4h
Main test: 4 h - Observation period:
- The animals were examined for signs of erythema and oedema 1 h after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.
- Number of animals:
- Initial test: 1
Main test: 3 - Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 72 h
SCORING SYSTEM: Erythema and eschar formation, oedema form
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animals 2 and 3
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: animals 2 and 3
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: animals 2 and 3
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other: animals 2 and 3
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: animals 1, 2 and 3
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: animals 1, 2 and 3
- Time point:
- other: 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: animals 1, 2 and 3
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: animals 1, 2 and 3
- Time point:
- other: 72 h
- Score:
- 0
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: animals 1, 2 and 3
- Time point:
- other: 1h
- Score:
- 0
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: animals, 1, 2 and 3
- Time point:
- other: 24 h
- Score:
- 0
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: animals 1,2 and 3
- Time point:
- other: 48 h
- Score:
- 0
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- other: systemic findings, specific local findings
- Basis:
- other: animals 1, 2 and 3
- Time point:
- other: 72 h
- Score:
- 0
- Remarks on result:
- other: no systemic findings, no specific local findings
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Initial test.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 0
- Remarks on result:
- other: Initial test.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 0
- Remarks on result:
- other: Initial test.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 0
- Remarks on result:
- other: Iniital test.
- Irritant / corrosive response data:
- The initial test in animal no.1: The examination of the test site immediately after the patch removal revealed erythema grade 1, the subsequent clinical observation showed erythema grade 1 after 1 h, but no corrosive effects.
The test item showed neither irritant nor corrosive effects on the intact skin in the other 2 animals at any time.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritant, not corrosive.
- Executive summary:
Under the conditions of the study the single dermal application of the test item L181 to rabbits at a dose of 0.5 g showed slightly irritant but no corrosive effects in one animal, which were fully reversible within 24 h.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the criteria for classification and labeling requirements of the CLP-regulation 1272/2008 (as well as the DSD 2001/59/EC), the test item L181 does not have to be classified and has no obligatory requirement for skin 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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