Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-11-19 - 2010-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Recombinant spider silk protein eADF4(C16) derived from E. Coli by fermentation
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Recombinant spider silk protein eADF4(C16) derived from E. Coli by fermentation
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- other: pyrogenfree HEPES buffer
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test item (corresponding to a dose of 0.3 mg/animal)
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause any signs of pain reaction or any clinical findings.
- Executive summary:
The test item did not cause any signs of pain reaction or any clinical findings.
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