Registration Dossier
Registration Dossier
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EC number: 273-761-1 | CAS number: 69012-64-2 Amorphous silicon dioxide particles from the volatilization and vaporization of furnace feed materials in the manufacture of ferrosilicon and silicon.
Eye irritation
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:
- 2 004
- 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
- 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
Constituent 1
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.
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