Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientific review by authorative international body.

Data source

Reference
Reference Type:
review article or handbook
Title:
SIDS initial assessment report for SIAM 19. Synthetic amorphous silica and silicates.
Author:
OECD
Year:
2004
Bibliographic source:
UNEP Publications, Berlin.

Materials and methods

Principles of method if other than guideline:
OECD evaluated the available test data on synthetic amorphous silica.
GLP compliance:
no
Remarks:
Review - both yes and no

Test material

Constituent 1
Reference substance name:
112945-52-5; 112926-00-8
IUPAC Name:
112945-52-5; 112926-00-8
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Tradenames: Aerosil 200; Sipernat 22S; Sident 9; ULTRASIL VN 3; Syloid 244; Zeofree 80; Tixosil 63; Tixosil 375

Test animals

Species:
rabbit

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Time point:
other: 24 hours
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: hydrophilic precipitated silica; slight erythemas in 4/6 animals
Irritant / corrosive response data:
The studies with synthetic amorphous shoved that silica were not irritating to the skin of a rabbit.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
OECD (2004) includes eight skin irritation studies, of which three were regarded as critical studies for SIDS endpoint. These three studies were conducted with hydrophilic pyrogenic or precipitated silica. None of the studies showed skin irritating effects.
Executive summary:

In OECD (2004), hydrophilic pyrogenic or precipitated silica were tested by exposing rabbits to 0.19 g or 0.5 g of dry or moistened test item under occlusive conditions for 4 or 24 hours. These synthetic amorphous silica were not irritating to skin under experimental conditions. However, these compounds may produce skin dryness following prolonged and repeated exposure.