Registration Dossier
Registration Dossier
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EC number: 231-545-4 | CAS number: 7631-86-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- Federal Hazardous Substance Act, 1973
- Principles of method if other than guideline:
- single administration, not rinsed, 72-hour post observation
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- precipitated, CAS-No.: 112926-00-8
Constituent 1
- Specific details on test material used for the study:
- amorphous silicon dioxide Zeo 49
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or tissues and environmental conditions:
- Purina Rabbit Chow (feed) and tap water ad libitum
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg (= 0.1 ml)
- Duration of treatment / exposure:
- once, not rinsed
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- applied into the conjunctival sac of the right eye of each animal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 - #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.3
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- Only one animal showed mild redness after 24 and 48 hours, but fully reversible at 72 hours. The total irritation score was 0.3 at 24 and 48 hours, and 0.0 at 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Federal Hazardous Substances Act amorphous silicon dioxide Zeo 49 was not irritating to rabbit eye
- Executive summary:
The eye irritation potential of amorphous silicon dioxide Zeo 49 was evaluated in rabbits.
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