Registration Dossier
Registration Dossier
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EC number: 636-196-5 | CAS number: 6902-77-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Performed outside the EU as part of academic medical research Published data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Performed as biological screening prior to work as medicinal product outside the EU
Published data in peer reviewed journal
Individual animal data not included in the publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Genipin in an Ex Vivo Corneal Model of Bacterial and Fungal Keratitis
- Author:
- Elena Koudounaet al
- Year:
- 2 021
- Bibliographic source:
- Transl Vis SciTechnol. 2021;10(9):31,
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Performed with Draize scoring to meet GHS criteria
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Genipin
- EC Number:
- 636-196-5
- Cas Number:
- 6902-77-8
- Molecular formula:
- C11H14O5
- IUPAC Name:
- Genipin
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 5 males, 5 females
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- Up to 15 days post treatment
- Number of animals or in vitro replicates:
- 5 males, 5 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Includes chemosis in results
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- Note that individual data has not been presented for the animals and only Draize scoring information provided. The total scores indicate borderline Eye Irrit 2 and non-classified
- Other effects:
- Not reported
Applicant's summary and conclusion
- Conclusions:
- Note that individual data has not been presented for the animals and only Draize scoring information provided. The total scores indicate borderline Eye Irrit 2 and non-classified
It is noted that this in-vivo assay to verify eye irritation before conducting an in-vitro assessment on corneal repair materials was no in accordance with European ethical procedures.
However, the published data provides evidence of low irritation to eyes in terms of corneal damage, but resulted in chemosis.
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