Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
2003
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

Constituent 1
Reference substance name:
Magnesium aluminium silicate
IUPAC Name:
Magnesium aluminium silicate
Constituent 2
Reference substance name:
VEEGUM
IUPAC Name:
VEEGUM
Constituent 3
Reference substance name:
sodium magnesium silicate
IUPAC Name:
sodium magnesium silicate
Constituent 4
Reference substance name:
Hectorite
IUPAC Name:
Hectorite
Details on test material:
Various silicates.

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.