Registration Dossier
Registration Dossier
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EC number: 310-060-2 | CAS number: 102110-59-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Evaluation of an authoritative institution (Cosmetic Ingredient Review Expert Panel). Read-across to other silicates.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: evaluation
- Title:
- Final report on the safety assessment of aluminum silicate, calcium silicate, magnesium aluminum silicate, magnesium silicate, magnesium trisilicate, sodium magnesium silicate, zirconium silicate, attapulgite, bentonite, Fuller's earth, hectorite, kaolin.
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 003
- Bibliographic source:
- Int J Toxicol 22(Suppl. 1):37–102
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The safety of using different silicates as cosmetic ingredients was assessed by the Cosmetic Ingredient Review Expert Panel (established by the industry trade association with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. CIR and the review process are independent from the Council and the cosmetics industry). All available data on possible irritating properties of the silicates were evaluated by the panel. For skin irritation animal studies with magnesium aluminium silicate, sodium magnesium silicate and hectorite were assessed.
- GLP compliance:
- no
Test material
- Reference substance name:
- Magnesium aluminium silicate
- IUPAC Name:
- Magnesium aluminium silicate
- Reference substance name:
- VEEGUM
- IUPAC Name:
- VEEGUM
- Reference substance name:
- sodium magnesium silicate
- IUPAC Name:
- sodium magnesium silicate
- Reference substance name:
- Hectorite
- IUPAC Name:
- Hectorite
- Details on test material:
- Various silicates.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24 and 72 h
- Score:
- 0.1
- Remarks on result:
- other: For magneisum aluminium silicate
- Irritation parameter:
- other: cumulative irritation index
- Score:
- 0
- Remarks on result:
- other: For magnesium aluminium silicate and sodium magnesium silicate
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0
- Remarks on result:
- other: For sodium magnesium silicate
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Magnesium aluminium silicate was only slightly irritating when applied to intact or abraded rabbit skin. Sodium magnesium silicate caused no primary irritation. CIR concluded that these silicates can safely be used as cosmetic ingredients.
- Executive summary:
The safety of using different silicates as cosmetic ingredients was assessed by the Cosmetic Ingredient Review Expert Panel (established by the industry trade association with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. CIR and the review process are independent from the Council and the cosmetics industry). All available data on possible irritating properties of the silicates were evaluated by the panel. For skin irritation animal studies with magnesium aluminium silicate, sodium magnesium silicate and hectorite were assessed.
Magnesium aluminium silicate was only slightly irritating when applied to intact or abraded rabbit skin. Sodium magnesium silicate or hectorite caused no primary irritation. CIR concluded that these silicates can safely be used as cosmetic ingredients.
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