Registration Dossier
Registration Dossier
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EC number: 208-517-5 | CAS number: 531-75-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- The effect of deacetylated gellan gum on aesculin distribution in the posterior segment of the eye after topical administration
- Author:
- Qiuhong Chen, Yu Zheng, Ye Li, Ying Zeng, JianChao Kuang, Shixiang Hou & Xiaohui Li
- Year:
- 2 012
- Bibliographic source:
- Drug Delivery, 2012; 19(4): 194–201 © 2012 Informa Healthcare USA, Inc. ISSN 1071-7544 print/ISSN 1521-0464 online DOI: 10.3109/10717544.2012.690003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- data source is a publication from China, no information about European GLP
Test material
- Reference substance name:
- Aesculin
- EC Number:
- 208-517-5
- EC Name:
- Aesculin
- Cas Number:
- 531-75-9
- Molecular formula:
- C15H16O9
- IUPAC Name:
- aesculin
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- 1.0 mg/ml Aesculin in deionized water containing 4% (w/w) of D-mannitol
Constituent 1
- Specific details on test material used for the study:
- The aesculin solution was prepared by dissolving a certain amount of aesculin (1.0 mg/mL) in deionized water containing 4% (w/w) of D-mannitol. pH of the formulation was adjusted to 7.4 ± 0.5 by trolamine.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- water
- Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 50µl
- Concentration (if solution): 1mg/ml
:- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 2, 4, 24, 48, 72 hours, 7 days
- Number of animals or in vitro replicates:
- 12
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Aesculin solution was well tolerated by the rabbits and no macroscopic signs of tearing, irritation, redness or other toxic effects were observed. Furthermore, there were no obvious histological changes in the ocular tissues, such as inflammatory infiltration, hemorrhage, and necrosis.
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