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Toxicological information

Eye irritation

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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:
2012
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:
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
Name:
Unnamed
Type:
Constituent
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
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.