Registration Dossier
Registration Dossier
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EC number: 215-685-3 | CAS number: 1344-01-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by GLP compliant laboratory using OECD Testing Guideline 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silicic acid, aluminum, calcium, sodium salt
- IUPAC Name:
- Silicic acid, aluminum, calcium, sodium salt
- Reference substance name:
- Silicic acid, aluminum calcium sodium salt
- EC Number:
- 215-685-3
- EC Name:
- Silicic acid, aluminum calcium sodium salt
- Cas Number:
- 1344-01-0
- Molecular formula:
- 3.0-3.9 SiO2 . Al2O3 . 0.4-0.6 CaO . 0.4-0.6 Na2O . nH2O
- IUPAC Name:
- aluminium(3+) calcium sodium tris(oxosilanebis(olate))
- Test material form:
- other: solid
- Details on test material:
- Physical state: solid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.4 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.17
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.03
Any other information on results incl. tables
4 hours after application of the test material, erythema grade one was observed. This had disappeared 24 hours after application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was not found to be a skin irritant with a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 recorded 48 hours after application of the substance. The substance is therefore not considered a skin irritant.
- Executive summary:
The skin irritation potential of the substance was determined in accordance with the OECD Guideline for Testing of Chemiclas 404. The substance was applied in semi-occlusive coverage to the clipped skin of rabbits. After 48 hours a mean erythema score of 0.17, a mean oedema score of 0 and a mean overall irritation score of 0.03 was recorded. The substance is not classified as a skin irritant according to EU CLP criteria.
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