Registration Dossier

Administrative data

Endpoint:
eye 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:
112926-00-8; 112945-52-5
IUPAC Name:
112926-00-8; 112945-52-5
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Tradenames: Aerosil 200; Sident 9; Sipernat 22S; Syloid 244; Zeo 49, Zeosyl 113, Zeosyl 200 and Zeofree 153; Zeofree 80

Test animals / tissue source

Species:
rabbit

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: hydrophilic precipitated silica; redness 2 after 1h, and 2 and 1 after 24 h; very slight chemosis and discharge after 1h
Irritation parameter:
conjunctivae score
Time point:
other: no data
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: hydrophilic precipitated silica
Irritant / corrosive response data:
The studies with synthetic amorphous silica did not cause eye irritation on rabbit.

Any other information on results incl. tables

Non of the studies in the review was showing eye irritation.

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 six eye irritation studies with synthetic amorphous silica, of which two were regarded as critical studies for SIDS endpoint. These two studies were conducted with hydrophilic precipitated silica. None of the studies showed eye irritating effects on rabbit.
Executive summary:

In OECD (2004), all synthetic amorphous silica products tested as a powder (0.1 g) have shown no or only weak and transient irritating effects on the conjunctivae of the eyes of rabbits with the iris and cornea not affected at all. In conclusion, synthetic amorphous silica are not irritating to eyes under experimental conditions.