Registration Dossier
Registration Dossier
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EC number: 215-105-9 | CAS number: 1302-67-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-09-03 - 2009-09-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Draft Proposal for a new guideline, In vitro Skin Irritation: Human Skin Model, 2007
- Deviations:
- yes
- Remarks:
- In the pre-test, 1 ml water demin. was used instead of 0.3 ml.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Spinel (Mg(AlO2)2)
- EC Number:
- 215-105-9
- EC Name:
- Spinel (Mg(AlO2)2)
- Cas Number:
- 1302-67-6
- Molecular formula:
- AlO2.1/2Mg
- IUPAC Name:
- magnesium dialuminium oxide
- Details on test material:
- Purity: > 99%
Batch no.: SP-AR78 -20MY, 0825193518
Constituent 1
Test animals
- Species:
- other: Human Skin, Epi-200-Kit
- Strain:
- other: MatTek Corporation in Ashland, USA
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3 tissues as neagtive controls without test item
- Amount / concentration applied:
- Tissue 1: 25.7 mg
Tissue 2: 24.3 mg
Tissue 3: 24.5 mg - Duration of treatment / exposure:
- 60 minutes
- Observation period:
- 60 minutes
- Number of animals:
- 3 tissues were used.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: %Formazan Production
- Value:
- 102
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Max. score: 50.0. Reversibility: no data. (migrated information)
In vivo
- Irritant / corrosive response data:
- % Formazan production Assessment
< 50% of negative control Irritant
> 50% of negative control Non-irritant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is considered not irritant.
After the treatment, the relative absorbance values were increased to 102.7%. This value is well above the threshold for irritation (50%). - Executive summary:
The test item is considered not irritant.
After the treatment, the relative absorbance values were increased to 102.7%. This value is well above the threshold for irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 8.1 % (required:<20%) for thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.
For these reasons, the result of the test is considered valid.
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