Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Chemical burns of the rabbit cornea.
Author:
Carpenter CP, Smyth HF
Year:
1946
Bibliographic source:
Am J Ophthal 29: 1363-1372

Materials and methods

Principles of method if other than guideline:
Estimation of eye hazard within a range-finding test.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL undiluted diethylene glycol
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
5
Details on study design:
The individual numerical scores of each eye treated were added together and then divided by the number of treated eyes (usually 5 animals) to obtain the score of the injury caused by the treatment. The level of 5.0 was selected by the authors of the study as representative of severe injury.
When a test is to be performed, normal albino rabbits are selected on the basis of absence of grossly visible staining of the eye by a 5% aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. After a two-hour interval to allow the eye to return normal, the undiluted material is applied to the centre of the cornea while the lids are retracted. Eighteen to 24 hours later, the eye is examined in strong diffuse daylight, and then stained with fluorescein, and the injury scored. Guided by the result and the table of injury grades, additional applications are made until the chemical can be assigned to one of the grades they recognize.

Results and discussion

In vivo

Results
Irritation parameter:
other: ocular irritation
Basis:
mean
Remarks:
all animals
Time point:
24 h
Score:
1
Max. score:
10
Reversibility:
not specified
Remarks on result:
other: 0.5 mL 0.5 mL undiluted gives injury of 0 to 1.0 points
Remarks:
Grade 1
Irritant / corrosive response data:
No occular irritation was noticed after application of 0.5 mL of undiluted test item.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met